Analysis of Root Coverage Stability.

NCT05439382 | Active Not Recruiting DMC

• 1 other identifier: RB008723
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.

Conditions

Gingival Recession; Surgery; Oral Disease

Keywords

Gingival recession; Root coverage; Subepithelial tissue graft

Outcome Measures

Primary Outcomes (5)

• Periodontal pocket probing depth (PD)

  Measurements of the periodontal pocket depth in millimeters

  From surgery to December 2023

• Keratinized tissue width (KTW)

  Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction

  From surgery to December 2023

• Gingival recession depth (RD)

  Measurements of the depth of the gingival recession, in millimeters, from the cementoenamel junction to the most apical part of the gingival recession

  From surgery to December 2023

• Gingival recession width (RW)

  Measurements of the width of the gingival recession, in millimeters, from the mesial to distal part of the uncovered cementoenamel junction

  From surgery to December 2023

• Gingival recession area (RA)

  Measurements of the area, in square millimeters, of the gingival recession

  From surgery to December 2023

Secondary Outcomes (5)

• Correlation between initial and late measurements of probing depth (PD)

  From surgery to December 2023

• Correlation between initial and late measurements of keratinized tissue width (KTW)

  From surgery to December 2023

• Correlation between initial and late measurements of gingival recession depth (RD)

  From surgery to December 2023

• Correlation between initial and late measurements of gingival recession width (RW)

  From surgery to December 2023

• Correlation between initial and late measurements of gingival recession area (RA)

  From surgery to December 2023

Study Arms (3)

Langer & Langer technique

Participants undergoing Langer \& Langer surgical technique

Procedure: Gingival recession regenerative surgery

Nelson' modified technique

Participants undergoing Nelson' modified surgical technique

Procedure: Gingival recession regenerative surgery

Coronally advanced flap and subepithelial graft

Participants undergoing Coronally advanced flap and subepithelial graft surgical technique

Procedure: Gingival recession regenerative surgery

Interventions

Gingival recession regenerative surgery PROCEDURE

Bilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap

Coronally advanced flap and subepithelial graft; Langer & Langer technique; Nelson' modified technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants screened for the presence of at least one tooth presenting with gingival recession requiring subepithelial tissue graft (bilaminar technique), examined and treated from 1987 at the Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of Modena University Hospital.

You may qualify if:

• Absence of relevant medical conditions: Medical history of good health. Good oral hygiene: full-mouth plaque score (FMPS) ≤20%. Low level of residual infection: full-mouth bleeding score (FMBS) ≤20%. Participants showing good levels of compliance were selected. Presence of at least one tooth presenting with gingival recession (GR) requiring subepithelial tissue graft, and with identifiable cement-enamel junction (CEJ).
• GR exhibiting an identifiable cemento-enamel junction, and absence of plaque or bleeding on probing (BoP) in the sites scheduled for the procedure.
• GR defects Miller Class I or II without furcation involvement.

You may not qualify if:

• Pregnant or lactating. Smokers and participants with history of alcohol abuse. Periodontal disease.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• University of Modena and Reggio Emilia: collaborator
• University of Firenze and Siena, Napoli, Italy: collaborator
• The European Research Group on Periodontology (ERGOPerio): collaborator

Study Sites (1)

Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of the Modena University Hospital

Modena, 41124, Italy

Location

Related Publications (14)

• Rasperini G, Acunzo R, Pellegrini G, Pagni G, Tonetti M, Pini Prato GP, Cortellini P. Predictor factors for long-term outcomes stability of coronally advanced flap with or without connective tissue graft in the treatment of single maxillary gingival recessions: 9 years results of a randomized controlled clinical trial. J Clin Periodontol. 2018 Sep;45(9):1107-1117. doi: 10.1111/jcpe.12932. Epub 2018 Aug 20.

  PMID: 29777632 BACKGROUND

• Chambrone L, Tatakis DN. Long-Term Outcomes of Untreated Buccal Gingival Recessions: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jul;87(7):796-808. doi: 10.1902/jop.2016.150625. Epub 2016 Feb 15.

  PMID: 26878749 BACKGROUND

• Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.

  PMID: 30277568 BACKGROUND

• Pini-Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions: a split-mouth study with a 5-year follow-up. J Clin Periodontol. 2010 Jul;37(7):644-50. doi: 10.1111/j.1600-051X.2010.01559.x. Epub 2010 May 11.

  PMID: 20492074 BACKGROUND

• Pini Prato GP, Franceschi D, Cortellini P, Chambrone L. Long-term evaluation (20 years) of the outcomes of subepithelial connective tissue graft plus coronally advanced flap in the treatment of maxillary single recession-type defects. J Periodontol. 2018 Nov;89(11):1290-1299. doi: 10.1002/JPER.17-0619. Epub 2018 Aug 10.

  PMID: 29873085 BACKGROUND

• Francetti L, Weinstein R, Taschieri S, Corbella S. Coronally Advanced Flap With or Without Subepithelial Connective Tissue Graft for the Treatment of Single Recession: 5-Year Outcomes from a Comparative Study. Int J Periodontics Restorative Dent. 2018 November/December;38(6):819-825. doi: 10.11607/prd.3036. Epub 2018 Feb 16.

  PMID: 29451926 BACKGROUND

• Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. doi: 10.1902/jop.2006.050450.

  PMID: 17076617 BACKGROUND

• Leknes KN, Amarante ES, Price DE, Boe OE, Skavland RJ, Lie T. Coronally positioned flap procedures with or without a biodegradable membrane in the treatment of human gingival recession. A 6-year follow-up study. J Clin Periodontol. 2005 May;32(5):518-29. doi: 10.1111/j.1600-051X.2005.00706.x.

  PMID: 15842269 BACKGROUND

• Nickles K, Ratka-Kruger P, Neukranz E, Raetzke P, Eickholz P. Ten-year results after connective tissue grafts and guided tissue regeneration for root coverage. J Periodontol. 2010 Jun;81(6):827-36. doi: 10.1902/jop.2010.090632.

  PMID: 20450359 BACKGROUND

• Kuis D, Sciran I, Lajnert V, Snjaric D, Prpic J, Pezelj-Ribaric S, Bosnjak A. Coronally advanced flap alone or with connective tissue graft in the treatment of single gingival recession defects: a long-term randomized clinical trial. J Periodontol. 2013 Nov;84(11):1576-85. doi: 10.1902/jop.2013.120451. Epub 2013 Feb 22.

  PMID: 23432657 BACKGROUND

• Zucchelli G, Mounssif I, Mazzotti C, Stefanini M, Marzadori M, Petracci E, Montebugnoli L. Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):396-403. doi: 10.1111/jcpe.12224. Epub 2014 Jan 22.

  PMID: 24382170 BACKGROUND

• Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.

  PMID: 28304210 BACKGROUND

• Barootchi S, Tavelli L, Di Gianfilippo R, Byun HY, Oh TJ, Barbato L, Cairo F, Wang HL. Long term assessment of root coverage stability using connective tissue graft with or without an epithelial collar for gingival recession treatment. A 12-year follow-up from a randomized clinical trial. J Clin Periodontol. 2019 Nov;46(11):1124-1133. doi: 10.1111/jcpe.13187. Epub 2019 Sep 9.

  PMID: 31446625 RESULT

• Bertoldi C, Consolo U, Lalla M, Zaffe D, Tanza D, Cairo F, Cortellini P. Long-term stability (21-30 years) of root coverage outcomes using sub-epithelial connective tissue grafts at single or multiple gingival recessions: A longitudinal case series. J Clin Periodontol. 2024 Jan;51(1):2-13. doi: 10.1111/jcpe.13882. Epub 2023 Oct 5.

  PMID: 37794814 DERIVED

MeSH Terms

Conditions

Gingival Recession; Mouth Diseases

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Carlo Bertoldi, MD DDS

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 30, 2022
• Study Start: January 1, 1987
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)