Trial Outcomes & Findings for Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment (NCT NCT02397122)
NCT ID: NCT02397122
Last Updated: 2018-10-26
Results Overview
Measured from cementoenamel junction to margin of the gingiva by periodontal probe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline, 6 weeks and 6 months
Results posted on
2018-10-26
Participant Flow
Fifty-eight patients that did not comply with the inclusion criteria were not chosen for the study
Participant milestones
| Measure |
CAF+CTG+PRF
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
coronally advanced flap + connective tissue graft
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
Baseline characteristics by cohort
| Measure |
CAF+CTG+PRF
n=20 Participants
A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group and the CAF was primarily closed.
|
CAF+CTG
n=20 Participants
A computer-generated randomization scheme (simple randomization without any blocking) was used to assign 20 patients into each study groups with an allocation ratio of 1:1 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. CTG was placed over the exposed root surface and the CAF was primarily closed onto it.
|
Total
n=40 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.80 years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
39.65 years
STANDARD_DEVIATION 6.46 • n=7 Participants
|
40.72 years
STANDARD_DEVIATION 7.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsMeasured from cementoenamel junction to margin of the gingiva by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Vertical Recession
Baseline
|
3.35 mm
Standard Deviation 0.43
|
3.20 mm
Standard Deviation 0.34
|
|
Vertical Recession
6 weeks
|
0.38 mm
Standard Deviation 0.54
|
0.65 mm
Standard Deviation 0.59
|
|
Vertical Recession
6 months
|
0.35 mm
Standard Deviation 0.52
|
0.65 mm
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: Data pertaining to 20 patients from each group were analysed after completing 6 months period
measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Horizontal Recession
Baseline
|
3.8 mm
Interval 2.0 to 5.0
|
3 mm
Interval 2.0 to 5.0
|
|
Horizontal Recession
6 weeks
|
0 mm
Interval 0.0 to 3.0
|
1 mm
Interval 0.0 to 3.0
|
|
Horizontal Recession
6 months
|
0 mm
Interval 0.0 to 3.0
|
1 mm
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: Data pertaining to 20 patients from each group were analysed after completing 6 months period
measured from margin of the gingiva to gingival sulcus base by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Probing Depth
6 weeks
|
1 mm
Interval 1.0 to 1.0
|
1 mm
Interval 1.0 to 2.0
|
|
Probing Depth
6 months
|
1 mm
Interval 1.0 to 1.0
|
1 mm
Interval 1.0 to 2.0
|
|
Probing Depth
Baseline
|
1 mm
Interval 1.0 to 2.0
|
1 mm
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: Data pertaining to 20 patients from each group were analysed after completing 6 months period
measured from cementoenamel junction to gingival sulcus base by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Attachment Level
Baseline
|
4.5 mm
Interval 3.0 to 5.5
|
4 mm
Interval 3.0 to 5.0
|
|
Attachment Level
6 weeks
|
1 mm
Interval 1.0 to 3.0
|
2 mm
Interval 1.0 to 3.0
|
|
Attachment Level
6 months
|
1 mm
Interval 1.0 to 3.0
|
1.8 mm
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: Data pertaining to 20 patients from each group were analysed after completing 6 months period
measured from margin of the gingiva to mucogingival junction by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Keratinized Tissue Width
Baseline
|
3 mm
Interval 2.0 to 6.0
|
2.8 mm
Interval 2.0 to 6.0
|
|
Keratinized Tissue Width
6 weeks
|
4 mm
Interval 2.0 to 7.5
|
3.5 mm
Interval 1.5 to 7.0
|
|
Keratinized Tissue Width
6 months
|
4 mm
Interval 2.0 to 7.5
|
3.8 mm
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks and 6 monthsPopulation: Data pertaining to 20 patients from each group were analysed after completing 6 months period
under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe
Outcome measures
| Measure |
PRF+CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
CAF+CTG
n=20 Participants
platelet-rich fibrin + coronally advanced flap + connective tissue graft
platelet-rich fibrin: autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
connective tissue graft: connective tissue graft was harvested from the palatal region of each patient by single incision method
coronally advanced flap: buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
|
|---|---|---|
|
Tissue Thickness
Baseline
|
0.9 mm
Interval 0.4 to 1.6
|
0.9 mm
Interval 0.4 to 1.6
|
|
Tissue Thickness
6 weeks
|
1.9 mm
Interval 1.4 to 2.6
|
1.6 mm
Interval 0.9 to 2.6
|
|
Tissue Thickness
6 months
|
1.9 mm
Interval 1.4 to 2.6
|
1.5 mm
Interval 1.0 to 2.2
|
Adverse Events
PRF+CAF+CTG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAF+CTG
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