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

NCT03199118 | Completed Results

• 1 other identifier: sarahelbanna84
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Keywords

root coverage

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline-3 months-6 months

Secondary Outcomes (9)

• Recession Width

  baseline-3 months-6 months

• Root Coverage Gain

  at 6 months

• Probing Depth

  baseline-3 months-6 months

• Clinical Attachment Level

  baseline-3 months-6 months

• Gingival Biotype

  baseline-3 months-6 months

Study Arms (2)

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)

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

Procedure: CAF +SCTG

Interventions

CAF +SCTG PROCEDURE

the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession

Also known as: CTG

CAF+SCTG; CAF+SCTG+PRF

platelet rich fibrin OTHER

in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession

Also known as: PRF

CAF+SCTG+PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.
• \) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene

You may not qualify if:

• \- 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 .
• \) Teeth with cervical restorations, abrasion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Cairo, 12345, Egypt

Location

Related Publications (14)

• 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.

  PMID: 12516830 BACKGROUND

• Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.

  PMID: 7928129 BACKGROUND

• Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.

  PMID: 12516826 BACKGROUND

• Keceli 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.

  PMID: 26177630 BACKGROUND

• Marx 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.

  PMID: 9638695 BACKGROUND

• Michaelides PL, Wilson SG. An autogenous gingival graft technique. Int J Periodontics Restorative Dent. 1994 Apr;14(2):112-25.

  PMID: 7928128 BACKGROUND

• Okuda 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.

  PMID: 12886996 BACKGROUND

• Paolantonio 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.

  PMID: 12479634 BACKGROUND

• Petrungaro 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.

  PMID: 11993379 BACKGROUND

• Pini-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.

  PMID: 10505810 BACKGROUND

• Roccuzzo 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.

  PMID: 12787218 BACKGROUND

• Tozum TF, Demiralp B. Platelet-rich plasma: a promising innovation in dentistry. J Can Dent Assoc. 2003 Nov;69(10):664.

  PMID: 14611717 BACKGROUND

• Wennstrom 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.

  PMID: 8877664 BACKGROUND

• Zucchelli 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.

  PMID: 9526912 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Sarah Elbanna, assistant lecturer at the Oral Medicine and Periodontology department
• Organization: Cairo University

srhelbanna@gmail.com

+201000760002

Study Officials

• Azza Ezzelarab

  Professor of periodontics, Faculty of dentistry, Cairo university

  STUDY DIRECTOR

• Noha Ghallab

  Professor of periodontics, Faculty of dentistry, Cairo university

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in the oral medicine and periodontology department

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 26, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 22, 2021
• Results First Posted: March 22, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)