Trial Outcomes & Findings for Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession (NCT NCT03199118)

NCT ID: NCT03199118

Last Updated: 2021-03-22

Results Overview

measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

baseline-3 months-6 months

Results posted on

2021-03-22

Participant Flow

Subjects were selected from the outpatient clinic,Faculty of Dentistry, Cairo University between 30/09/2017 and 1/08/ 2019 Patients \>18 Periodontally and systemically healthy Miller class I or II buccal recession defects Presence of identifiable CEJ Clinical indication and/or patient request for recession coverage.

5 patients were excluded for not meeting inclusion criteria

Participant milestones

Participant milestones
Measure
CAF+SCTG+PRF
Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
CAF+SCTG
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Overall Study
STARTED
14
14
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Total
n=28 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=99 Participants
14 Participants
n=107 Participants
28 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
9 Participants
n=99 Participants
8 Participants
n=107 Participants
17 Participants
n=206 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
6 Participants
n=107 Participants
11 Participants
n=206 Participants
Race/Ethnicity, Customized
white non hispanic
14 Participants
n=99 Participants
14 Participants
n=107 Participants
28 Participants
n=206 Participants
Region of Enrollment
Egypt
14 participants
n=99 Participants
14 participants
n=107 Participants
28 participants
n=206 Participants

PRIMARY outcome

Timeframe: baseline-3 months-6 months

measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Recession Depth
baseline
2 length in millimeters
Interval 1.0 to 4.0
2 length in millimeters
Interval 2.0 to 4.0
Recession Depth
3 months
0 length in millimeters
Interval 0.0 to 1.0
0 length in millimeters
Interval 0.0 to 1.0
Recession Depth
6 months
0 length in millimeters
Interval 0.0 to 1.0
0 length in millimeters
Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: baseline-3 months-6 months

It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Recession Width
baseline
1.5 length in millimeters (mm)
Interval 1.0 to 3.0
2 length in millimeters (mm)
Interval 1.0 to 3.0
Recession Width
3 months
0 length in millimeters (mm)
Interval 0.0 to 1.0
0 length in millimeters (mm)
Interval 0.0 to 1.0
Recession Width
6 months
0 length in millimeters (mm)
Interval 0.0 to 1.0
0 length in millimeters (mm)
Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: at 6 months

(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Root Coverage Gain
92.9 percentage of root coverage
Standard Deviation 18.2
91.6 percentage of root coverage
Standard Deviation 17.1

SECONDARY outcome

Timeframe: baseline-3 months-6 months

measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Probing Depth
baseline
1.71 length in millimeters(mm)
Standard Deviation 0.47
1.5 length in millimeters(mm)
Standard Deviation 0.65
Probing Depth
3 months
1.07 length in millimeters(mm)
Standard Deviation 0.27
1.07 length in millimeters(mm)
Standard Deviation 0.27
Probing Depth
6 months
1.07 length in millimeters(mm)
Standard Deviation 0.27
1.21 length in millimeters(mm)
Standard Deviation 0.27

SECONDARY outcome

Timeframe: baseline-3 months-6 months

measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Clinical Attachment Level
baseline
3.79 length in millimeters(mm)
Standard Deviation 0.97
4 length in millimeters(mm)
Standard Deviation 0.78
Clinical Attachment Level
3 months
2.14 length in millimeters(mm)
Standard Deviation 0.66
2.29 length in millimeters(mm)
Standard Deviation 0.73
Clinical Attachment Level
6 months
2 length in millimeters(mm)
Standard Deviation 0.69
2.07 length in millimeters(mm)
Standard Deviation 0.62

SECONDARY outcome

Timeframe: baseline-3 months-6 months

under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Gingival Biotype
baseline
1 length in millimeters(mm)
Interval 1.0 to 1.0
1 length in millimeters(mm)
Interval 1.0 to 1.0
Gingival Biotype
3 months
3 length in millimeters(mm)
Interval 2.0 to 3.0
2.5 length in millimeters(mm)
Interval 2.0 to 3.0
Gingival Biotype
6 months
3 length in millimeters(mm)
Interval 2.0 to 4.0
3 length in millimeters(mm)
Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: baseline-3 months-6 months

from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Width of Keratinized Gingiva
baseline
2.36 length in millimeters(mm)
Standard Deviation 0.63
2.64 length in millimeters(mm)
Standard Deviation 0.74
Width of Keratinized Gingiva
3 months
3.64 length in millimeters(mm)
Standard Deviation 1.08
3.71 length in millimeters(mm)
Standard Deviation 0.73
Width of Keratinized Gingiva
6 months
3.86 length in millimeters(mm)
Standard Deviation 1.03
4.14 length in millimeters(mm)
Standard Deviation 0.86

SECONDARY outcome

Timeframe: questionnaire given to the patient 6 months after the surgery

printed yes/ no questionnaire with 3 questions: 1. would you do this surgery again? 2. would you recommend this treatment to others? 3. are you satisfied with the results?

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Patient Satisfaction
71.4 percentage of patients satisfied
64.3 percentage of patients satisfied

SECONDARY outcome

Timeframe: 6 months

The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES. minimum value:0 maximum value: 10 which means better outcome for RES

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Root Coverage Esthetic Score (RES)
9.43 score on a scale
Standard Deviation 1.09
9.29 score on a scale
Standard Deviation 1.27

SECONDARY outcome

Timeframe: after 2 weeks from surgery

Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively

Outcome measures

Outcome measures
Measure
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group) CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Post Operative Pain
9 score on a scale
Interval 7.0 to 10.0
8.5 score on a scale
Interval 5.0 to 10.0

Adverse Events

CAF+SCTG+PRF

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

CAF+SCTG

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

Sarah Elbanna, assistant lecturer at the Oral Medicine and Periodontology department

Cairo University

Phone: +201000760002

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place