Trial Outcomes & Findings for Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession (NCT NCT03712852)
NCT ID: NCT03712852
Last Updated: 2022-11-29
Results Overview
the change from baseline measured as the thickness of keratinized tissue recorded at 1 mm from the gingival margin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2022-11-29
Participant Flow
Participant milestones
| Measure |
PRF+CAF Treated Patients
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession
Baseline characteristics by cohort
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 5 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 5 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Sex: Female, Male
Sex · Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Sex · Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Statistical software R 3.5.1 was used to analyze the clinical data. Descriptive statistics of GT was analyzed by non-parametric Cliff's delta tests to asses group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests.
the change from baseline measured as the thickness of keratinized tissue recorded at 1 mm from the gingival margin
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Gingival Thickness
|
1.97 millimeter
Standard Deviation 0.55
|
1.95 millimeter
Standard Deviation 0.28
|
1.39 millimeter
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: baseline and 6 monthsthe change from baseline measured as the distance between the cemento enamel junction and the gingival margin
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Gingival Recession
|
3.28 millimeter
Standard Deviation 0.59
|
3.70 millimeter
Standard Deviation 0.73
|
3.05 millimeter
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: baseline and 6 monthsthe change from baseline measured as the distance of the mid-buccal site of the gingival margin to the mucogingival junction
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Keratinized Tissue
|
0.08 millimeter
Standard Deviation 0.25
|
2.00 millimeter
Standard Deviation 0.97
|
-0.15 millimeter
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: baseline and 6 monthsthe change from baseline measured as the distance between the bottom of the pocket and the gingival margin
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Pocket Depth
|
0.20 millimeter
Standard Deviation 0.34
|
-0.10 millimeter
Standard Deviation 0.64
|
0.45 millimeter
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: baseline and 6 monthsthe change from baseline measured as the distance between the bottom of the pocket and the CEJ
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Clinical Attachment Level
|
3.38 millimeter
Standard Deviation 0.89
|
3.60 millimeter
Standard Deviation 0.60
|
3.40 millimeter
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 2 weeksA visual analogical scale (VAS) will be used to assess the patient morbidity after treatment. The scale has 10 numerical values, from 1(better outcome) to 10 (worse outcome).
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Patient Reported Outcomes (PROMs)
|
3.37 score on a scale
Standard Error 0.326
|
3.58 score on a scale
Standard Error 0.322
|
4.73 score on a scale
Standard Error 0.343
|
SECONDARY outcome
Timeframe: 6 monthsAesthetic outcome will be recorded using the root coverage esthetic score (RES) introduced by Cairo et al. in 2009. This score assess five domains: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Zero, 3, or 6 points will be used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables.The value assigned for root coverage will be 60% of the total score, whereas 40% will be assigned to the other four variables. 3 points will be given for partial root coverage, and 6 points will be given for complete root coverage; 0 points will be assigned when the final position of the gingival margin is equal or apical to the previous recession. One point will be assigned for each of the other four variables. Thus, 10 points will be a perfect score. 0-10 higher score indicates better outcome.
Outcome measures
| Measure |
PRF+CAF Treated Patients
n=20 Participants
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
PRF+CAF treated patients: Patients will be treated by coronally advanced flap with addition of PRF membrane
|
SCTG+ CAF Treated Patients
n=20 Participants
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, flap is coronally positioned and sutures over the enamel in a tension-free position.
SCTG+ CAF treated patients: Patients will be treated by coronally advanced flap with addition of SCTG graft
|
CAF Treated Patients
n=20 Participants
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
CAF treated patients: Patients will be treated by coronally advanced flap
|
|---|---|---|---|
|
Aesthetic
|
2.56 units on a scale
Standard Error 0.222
|
2.50 units on a scale
Standard Error 0.230
|
2.74 units on a scale
Standard Error 0.240
|
Adverse Events
PRF+CAF Treated Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SCTG+ CAF Treated Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAF Treated Patients
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
Prof. Michele Paolantonio
Università degli studi G. D'ANNUNZIO
Phone: 3395204073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place