Trial Outcomes & Findings for Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects (NCT NCT04718545)
NCT ID: NCT04718545
Last Updated: 2025-04-15
Results Overview
mRC measured as a percentage
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
up to 1 year
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Free Gingival Graft
A mucogingival surgery where a gingival graft harvested from the palate is placed on a conventionally prepared recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
Modified Free Gingival Graft
A mucogingival surgery where a gingival graft harvested from the palate is placed on a modified recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a conventionally prepared recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
Modified Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a modified recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 10.9 • n=15 Participants
|
35.8 years
STANDARD_DEVIATION 10.0 • n=15 Participants
|
36.2 years
STANDARD_DEVIATION 10.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Arab Emirates
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearmRC measured as a percentage
Outcome measures
| Measure |
Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a conventionally prepared recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
Modified Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a modified recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
|---|---|---|
|
Mean Mid-facial Recession Coverage (mRC)
|
60.7 percentage
Interval 56.0 to 65.3
|
91.8 percentage
Interval 87.1 to 96.4
|
SECONDARY outcome
Timeframe: up to 1 yearKT gain measured in mm
Outcome measures
| Measure |
Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a conventionally prepared recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
Modified Free Gingival Graft
n=15 Participants
A mucogingival surgery where a gingival graft harvested from the palate is placed on a modified recipient site and sutured to cover the mucosal recession
Mucogingival surgery: The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
|
|---|---|---|
|
Keratinized Tissue (KT) Gain
|
2.2 mm
Standard Deviation 0.9
|
4.2 mm
Standard Deviation 0.8
|
Adverse Events
Free Gingival Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Modified Free Gingival 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place