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Changes of Soft Tissue Grafting: A Randomized Study

Primary Purpose

Gingival Recession

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Split Mouth Design
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults 18yrs or older Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification) Class A +/- No class V restoration present Exclusion Criteria: Patients who do not consent to recommended therapy Patients who smoke Patients who will not be able to comply with follow up protocols Those who self report that they are pregnant.

Sites / Locations

  • Tufts University School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

Compare autologous PRF & Autogenous CTG
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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
January 12, 2023
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT05633511
Brief Title
Changes of Soft Tissue Grafting: A Randomized Study
Official Title
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
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Split Mouth Design
Intervention Description
PRF on one side of mouth and CTG on the other side of participant's mouth.
Primary Outcome Measure Information:
Title
Compare autologous PRF & Autogenous CTG
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 18yrs or older Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification) Class A +/- No class V restoration present Exclusion Criteria: Patients who do not consent to recommended therapy Patients who smoke Patients who will not be able to comply with follow up protocols Those who self report that they are pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tannaz Shapurian, DDM, MSc
Phone
617.636. 6741
Email
Tannaz.shapurian@tufts.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Leigh, DMD
Phone
617.636.6531
Email
Dan.Leigh@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tannaz Shapurian, DMD, MSc
Organizational Affiliation
Tufts University School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Papas
Email
dentalresearchadministration@tufts.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
24237738
Citation
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.
Results Reference
background
PubMed Identifier
24174758
Citation
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.
Results Reference
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PubMed Identifier
18584934
Citation
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.
Results Reference
background
PubMed Identifier
32369569
Citation
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.
Results Reference
background
PubMed Identifier
29087001
Citation
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.
Results Reference
background
PubMed Identifier
19792859
Citation
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.
Results Reference
background
PubMed Identifier
18190557
Citation
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.
Results Reference
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Links:
URL
https://www.scielo.br/j/jaos/a/p54RtZLrf8gL4fTzSndJ57z/?lang=en
Description
Evaluation of the effect of dose-dependent platelet-rich fibrin membrane on treatment of gingival recession: a randomized, controlled clinical trial

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Changes of Soft Tissue Grafting: A Randomized Study

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