Changes of Soft Tissue Grafting: A Randomized Study

Overview

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

Full Title of Study: “Volumetric Changes of Soft Tissue Grafting. Comparison of Autologous PRF (Platelet-rich Fibrin ) & Autogenous CTG (Connective Tissue Grafts) . A Split-mouth Randomized Design”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2024

Detailed Description

Patients that are interested in having corrective surgery for recession due to esthetic concerns or sensitivity will be enrolled in the study. The treatment site will randomly receive the procedure assignment. Intraoral scanner will be utilized to establish pre-op volume and will be repeated at each follow up visit. Total of 7visits and 12 mo duration is anticipated for the study.

Interventions

  • Procedure: Split Mouth Design
    • PRF on one side of mouth and CTG on the other side of participant’s mouth.

Arms, Groups and Cohorts

  • Experimental: All Participants
    • Participants will receive the CTG procedure on one side and the PRF procedure on the other. Both are standard of care soft tissue grafting methods and a split mouth design is standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Compare autologous PRF & Autogenous CTG
    • Time Frame: 12 months
    • Primary objective of this study is to compare in a split-mouth study the effectiveness of CTG vs. PRF in soft tissue augmentation and volume stability of each treatment modality in correcting the Cairo Class I, II defects in Periodontally affected patients

Participating in This Clinical Trial

Inclusion Criteria

1. Adults 18yrs or older 2. Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification) 3. Class A +/- 4. No class V restoration present Exclusion Criteria:

1. Patients who do not consent to recommended therapy 2. Patients who smoke 3. Patients who will not be able to comply with follow up protocols 4. Those who self report that they are pregnant.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tufts University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tannaz Shapurian, Associate Professor – Tufts University
  • Overall Official(s)
    • Tannaz Shapurian, DMD, MSc, Principal Investigator, Tufts University School of Dental Medicine
  • Overall Contact(s)
    • Tannaz Shapurian, DDM, MSc, 617.636. 6741, Tannaz.shapurian@tufts.edu

References

Nunn ME, Miyamoto T. Coronally advanced flaps (CAF) plus connective tissue graft (CTG) is the gold standard for treatment of Miller class I and II gingival defects. J Evid Based Dent Pract. 2013 Dec;13(4):157-9. doi: 10.1016/j.jebdp.2013.10.012. Epub 2013 Oct 11. No abstract available.

Padma R, Shilpa A, Kumar PA, Nagasri M, Kumar C, Sreedhar A. A split mouth randomized controlled study to evaluate the adjunctive effect of platelet-rich fibrin to coronally advanced flap in Miller's class-I and II recession defects. J Indian Soc Periodontol. 2013 Sep;17(5):631-6. doi: 10.4103/0972-124X.119281.

Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

Natto ZS, Parashis AO, Jeong YN. Soft-Tissue Changes After Using Collagen Matrix Seal or Collagen Sponge With Allograft in Ridge Preservation: A Randomized Controlled Volumetric Study. J Oral Implantol. 2020 Dec 1;46(6):588-593. doi: 10.1563/aaid-joi-D-19-00080.

Tonetti MS, Cortellini P, Pellegrini G, Nieri M, Bonaccini D, Allegri M, Bouchard P, Cairo F, Conforti G, Fourmousis I, Graziani F, Guerrero A, Halben J, Malet J, Rasperini G, Topoll H, Wachtel H, Wallkamm B, Zabalegui I, Zuhr O. Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life. J Clin Periodontol. 2018 Jan;45(1):78-88. doi: 10.1111/jcpe.12834. Epub 2017 Nov 21.

McLeod DE, Reyes E, Branch-Mays G. Treatment of multiple areas of gingival recession using a simple harvesting technique for autogenous connective tissue graft. J Periodontol. 2009 Oct;80(10):1680-7. doi: 10.1902/jop.2009.090187.

Keceli HG, Sengun D, Berberoglu A, Karabulut E. Use of platelet gel with connective tissue grafts for root coverage: a randomized-controlled trial. J Clin Periodontol. 2008 Mar;35(3):255-62. doi: 10.1111/j.1600-051X.2007.01181.x. Epub 2008 Jan 5.

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