Gingival RecessionNCT03199118
Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession
A study testing CAF +SCTG and platelet rich fibrin in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
Trial summary
This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF +SCTG and platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.
- 3) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene
Who cannot join
- 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .
- 7) Teeth with cervical restorations, abrasion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial
This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.
Read the detailed description
The study population will be divided into 2 groups:
Group 1:
Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years
Group 2:
Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.
- Conditions
- Gingival Recession
- Being tested
- CAF +SCTG, platelet rich fibrin
- Keywords
- root coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF +SCTGProcedure or surgery
Also called CTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
platelet rich fibrinOther
Also called PRF
in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession
| Study group | Role | What they receive |
|---|---|---|
| CAF+SCTG+PRF | Experimental | The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF) Receives: Procedure: CAF +SCTG; Other: platelet rich fibrin |
| CAF+SCTG | Active comparator | Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only Receives: Procedure: CAF +SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Depth
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.
Measured: baseline-3 months-6 months
Secondary outcomes (9)
Recession Width
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.
Measured: baseline-3 months-6 months
Root Coverage Gain
(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.
Measured: at 6 months
Probing Depth
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.
Measured: baseline-3 months-6 months
Clinical Attachment Level
measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).
Measured: baseline-3 months-6 months
Gingival Biotype
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.
Measured: baseline-3 months-6 months
Width of Keratinized Gingiva
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.
Measured: baseline-3 months-6 months
Patient Satisfaction
printed yes/ no questionnaire with 3 questions:
- would you do this surgery again?
- would you recommend this treatment to others?
- are you satisfied with the results?
Measured: questionnaire given to the patient 6 months after the surgery
Root Coverage Esthetic Score (RES)
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
Measured: 6 months
Post Operative Pain
Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively
Measured: after 2 weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elbanna, Cairo University
- Investigators
- Azza Ezzelarab, Study director, Professor of periodontics, Faculty of dentistry, Cairo universityNoha Ghallab, Study director, Professor of periodontics, Faculty of dentistry, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199118
- Sponsor's protocol ID
- sarahelbanna84
- Status last verified
- Feb 2021
- First submitted
- 21 Jun 2017
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berlucchi I, Francetti L, Del Fabbro M, Testori T, Weinstein RL. Enamel matrix proteins (Emdogain) in combination with coronally advanced flap or subepithelial connective tissue graft in the treatment of shallow gingival recessions. Int J Periodontics Restorative Dent. 2002 Dec;22(6):583-93.
PubMed 12516830Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
PubMed 7928129Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.
PubMed 12516826Keceli HG, Kamak G, Erdemir EO, Evginer MS, Dolgun A. The Adjunctive Effect of Platelet-Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects: Results of a Randomized, Parallel-Group Controlled Trial. J Periodontol. 2015 Nov;86(11):1221-30. doi: 10.1902/jop.2015.150015. Epub 2015 Jul 16.
PubMed 26177630Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.
PubMed 9638695Michaelides PL, Wilson SG. An autogenous gingival graft technique. Int J Periodontics Restorative Dent. 1994 Apr;14(2):112-25.
PubMed 7928128Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. doi: 10.1902/jop.2003.74.6.849.
PubMed 12886996Paolantonio M, Dolci M, Esposito P, D'Archivio D, Lisanti L, Di Luccio A, Perinetti G. Subpedicle acellular dermal matrix graft and autogenous connective tissue graft in the treatment of gingival recessions: a comparative 1-year clinical study. J Periodontol. 2002 Nov;73(11):1299-307. doi: 10.1902/jop.2002.73.11.1299.
PubMed 12479634Petrungaro P. Platelet-rich plasma for dental implants and soft-tissue grafting. Interview by Arun K. Garg. Dent Implantol Update. 2001 Jun;12(6):41-6. No abstract available.
PubMed 11993379Pini-Prato G, Baldi C, Pagliaro U, Nieri M, Saletta D, Rotundo R, Cortellini P. Coronally advanced flap procedure for root coverage. Treatment of root surface: root planning versus polishing. J Periodontol. 1999 Sep;70(9):1064-76. doi: 10.1902/jop.1999.70.9.1064.
PubMed 10505810Roccuzzo M, Bunino M, Needleman I, Sanz M. Periodontal plastic surgery for treatment of localized gingival recessions: a systematic review. J Clin Periodontol. 2002;29 Suppl 3:178-94; discussion 195-6. doi: 10.1034/j.1600-051x.29.s3.11.x.
PubMed 12787218Tozum TF, Demiralp B. Platelet-rich plasma: a promising innovation in dentistry. J Can Dent Assoc. 2003 Nov;69(10):664.
PubMed 14611717Wennstrom JL, Zucchelli G. Increased gingival dimensions. A significant factor for successful outcome of root coverage procedures? A 2-year prospective clinical study. J Clin Periodontol. 1996 Aug;23(8):770-7. doi: 10.1111/j.1600-051x.1996.tb00608.x.
PubMed 8877664Zucchelli G, Clauser C, De Sanctis M, Calandriello M. Mucogingival versus guided tissue regeneration procedures in the treatment of deep recession type defects. J Periodontol. 1998 Feb;69(2):138-45. doi: 10.1902/jop.1998.69.2.138.
PubMed 9526912
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03199118
- Acronym / sponsor ID
- sarahelbanna84
- Conditions
- Gingival Recession
- Keywords
- root coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.
Detailed description
The study population will be divided into 2 groups:
Group 1:
Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years
Group 2:
Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+SCTG+PRF | Experimental | Procedure: CAF +SCTG, Other: platelet rich fibrinThe patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF) |
| CAF+SCTG | Active comparator | Procedure: CAF +SCTGControl group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.
- 3) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene
Key exclusion criteria (2 listed)
- 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .
- 7) Teeth with cervical restorations, abrasion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAF +SCTGAlso: CTGthe use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession | Procedure or surgery | CAF+SCTG, CAF+SCTG+PRF |
| platelet rich fibrinAlso: PRFin addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession | Other | CAF+SCTG+PRF |
Primary outcome
Recession Depth
Time frame: 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.
9 secondary outcomes
Recession Width
Time frame: baseline-3 months-6 months
Root Coverage Gain
Time frame: at 6 months
Probing Depth
Time frame: baseline-3 months-6 months
Clinical Attachment Level
Time frame: baseline-3 months-6 months
Gingival Biotype
Time frame: baseline-3 months-6 months
Width of Keratinized Gingiva
Time frame: baseline-3 months-6 months
Patient Satisfaction
Time frame: questionnaire given to the patient 6 months after the surgery
Root Coverage Esthetic Score (RES)
Time frame: 6 months
Post Operative Pain
Time frame: after 2 weeks from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12516830Berlucchi I, Francetti L, Del Fabbro M, Testori T, Weinstein RL. Enamel matrix proteins (Emdogain) in combination with coronally advanced flap or subepithelial connective tissue graft in the treatment of shallow gingival recessions. Int J Periodontics Restorative Dent. 2002 Dec;22(6):583-93.
- Background: PubMed 7928129Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
- Background: PubMed 12516826Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.
- Background: PubMed 26177630Keceli HG, Kamak G, Erdemir EO, Evginer MS, Dolgun A. The Adjunctive Effect of Platelet-Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects: Results of a Randomized, Parallel-Group Controlled Trial. J Periodontol. 2015 Nov;86(11):1221-30. doi: 10.1902/jop.2015.150015. Epub 2015 Jul 16.
- Background: PubMed 9638695Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.
- Background: PubMed 7928128Michaelides PL, Wilson SG. An autogenous gingival graft technique. Int J Periodontics Restorative Dent. 1994 Apr;14(2):112-25.
- Background: PubMed 12886996Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. doi: 10.1902/jop.2003.74.6.849.
- Background: PubMed 12479634Paolantonio M, Dolci M, Esposito P, D'Archivio D, Lisanti L, Di Luccio A, Perinetti G. Subpedicle acellular dermal matrix graft and autogenous connective tissue graft in the treatment of gingival recessions: a comparative 1-year clinical study. J Periodontol. 2002 Nov;73(11):1299-307. doi: 10.1902/jop.2002.73.11.1299.
- Background: PubMed 11993379Petrungaro P. Platelet-rich plasma for dental implants and soft-tissue grafting. Interview by Arun K. Garg. Dent Implantol Update. 2001 Jun;12(6):41-6. No abstract available.
- Background: PubMed 10505810Pini-Prato G, Baldi C, Pagliaro U, Nieri M, Saletta D, Rotundo R, Cortellini P. Coronally advanced flap procedure for root coverage. Treatment of root surface: root planning versus polishing. J Periodontol. 1999 Sep;70(9):1064-76. doi: 10.1902/jop.1999.70.9.1064.
- Background: PubMed 12787218Roccuzzo M, Bunino M, Needleman I, Sanz M. Periodontal plastic surgery for treatment of localized gingival recessions: a systematic review. J Clin Periodontol. 2002;29 Suppl 3:178-94; discussion 195-6. doi: 10.1034/j.1600-051x.29.s3.11.x.
- Background: PubMed 14611717Tozum TF, Demiralp B. Platelet-rich plasma: a promising innovation in dentistry. J Can Dent Assoc. 2003 Nov;69(10):664.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza Ezzelarab study director
Professor of periodontics, Faculty of dentistry, Cairo university
Noha Ghallab study director
Professor of periodontics, Faculty of dentistry, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF +SCTG and platelet rich fibrin in people with Gingival Recession, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession Depth (time frame: baseline-3 months-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199118, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.