Trial Outcomes & Findings for Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft (NCT NCT06366022)
NCT ID: NCT06366022
Last Updated: 2026-05-14
Results Overview
Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%. * GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side * GR0- before surgery * GR6- 6 months after surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline and 6 months after surgery
Results posted on
2026-05-14
Participant Flow
Unit of analysis: Gingival recession defects
Participant milestones
| Measure |
The Tunnel Technique for Root Coverage With CTG With Inner Side of the Graft
A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study
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The Tunnel Technique for Root Coverage With CTG With Outer Side of the Graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study
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Overall Study
STARTED
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21 91
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21 84
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Overall Study
COMPLETED
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21 91
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21 84
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
Baseline characteristics by cohort
| Measure |
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft
n=91 Gingival recession defects
This was a randomized split-mouth clinical trial. Each participant received both interventions: one side was treated with the tunnel technique with a connective tissue graft (inner side), and the contralateral side with the same technique using the outer side of the graft. Assignment was at the gingival recession defect level.
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Modified Coronally Advanced Tunnel With Connective Tissue Graft With Outer Side of the Graft
n=84 Gingival recession defects
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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Total
n=175 Gingival recession defects
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
≤ 18 years
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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Age, Customized
19 years to 64 years
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21 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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21 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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21 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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Age, Customized
≥ 65 years
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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0 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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Sex/Gender, Customized
Female
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15 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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15 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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15 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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Sex/Gender, Customized
Male
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6 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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6 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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6 Participants
n=21 Participants • This was a split-mouth study design. Each participant could contribute gingival recession defects to both intervention groups. Therefore, the number of participants in each arm is the same, while the total number of unique participants is 21. The unit of analysis was the gingival recession defects.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Gingival recession height at baseline
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1.65 Milimeters
STANDARD_DEVIATION 0.82 • n=91 Gingival recession defects
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1.65 Milimeters
STANDARD_DEVIATION 0.82 • n=84 Gingival recession defects
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1.65 Milimeters
STANDARD_DEVIATION 0.82 • n=175 Gingival recession defects
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PRIMARY outcome
Timeframe: Baseline and 6 months after surgeryMean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%. * GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side * GR0- before surgery * GR6- 6 months after surgery
Outcome measures
| Measure |
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft
n=91 Gingival Recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with inner side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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Modified Coronally Advanced Tunnel With Connective Tissue Graft With Outer Side of the Graft
n=84 Gingival Recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with outer side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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Percent Change in Gingival Recession (Mean Root Coverage, MRC)
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95.00 Percent change (%)
Standard Error 19.56
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96.00 Percent change (%)
Standard Error 19.76
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SECONDARY outcome
Timeframe: 6 months after surgeryThe analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) \[millimetre\] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); \[millimetre\] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); \[millimetre\] higher scores mean better outcome * GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side * GT- gingival thickness * KTW- distance between the gingival margin and the muco-gingival junction (MGJ) * 0- before surgery * 6- 6 months after surgery
Outcome measures
| Measure |
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft
n=91 gingival recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with inner side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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Modified Coronally Advanced Tunnel With Connective Tissue Graft With Outer Side of the Graft
n=84 gingival recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with outer side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
GR change 6 months after surgery
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2.97 millimetres (mm)
Standard Error 0.90
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2.94 millimetres (mm)
Standard Error 0.95
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GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
GT change 6 months after surgery
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1.00 millimetres (mm)
Standard Error 0.40
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1.03 millimetres (mm)
Standard Error 0.45
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GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
KTW change 6 months after surgery
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1.88 millimetres (mm)
Standard Error 1.19
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1.89 millimetres (mm)
Standard Error 1.15
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after surgeryRES:The following variables were assessed: 1. GM - assessment rule: 0 points- root coverage failure, 3 points- partial root coverage, 6 points- complete root coverage; 2. marginal tissue contour (MTC) - assessment rule: 0 points - irregular gingival margin, not in line with the CEJ, 1 point- scalloped gingival contour, in line with the CEJ; 3. soft tissue texture (STT) - assessment rule: 0 points - scar formation, 1 point- absence of scars; 4. MGJ - assessment rule: 0 points - MGJ not aligned with the MGJ of adjacent teeth, 1 point- MGJ aligned with the MGJ of adjacent teeth; 5. gingival color (GC) - assessment rule: 0 points- color does not match adjacent teeth, 1 point- color matches adjacent teeth The maximum score for RES was 10, the minimum 0. Higher scores mean better outcome.
Outcome measures
| Measure |
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft
n=91 gingival recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with inner side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
|
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Outer Side of the Graft
n=84 gingival recessions
The study was designed as a randomized split-mouth clinical trial. Each participant received the same intervention. One side was treated with the tunnel technique with subepithelial connective tissue graft with outer side of the graft , while the other side was treated with the same method with outer side of the graft
This was a split-mouth study. Each participant contributed sites to both interventions. Participants may appear in more than one arm because the unit of assignment was the gingival recession site.
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Root Coverage Esthetic Score (RES)
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9.39 score on a scale
Standard Error 0.99
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9.12 score on a scale
Standard Error 1.54
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Adverse Events
Modified Coronally Advanced Tunnel With Connective Tissue Graft With Inner Side of the Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MCAT With SCTG With Outer Side of the Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
dr Bartłomiej Górski
Department of Periodontology and Oral Mucosa Diseases of Medical University of Warsaw
Phone: (22)2701616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place