CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL

NCT03862534 | Completed DMC

• 1 other identifier: RCT restored CEJ
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).

Conditions

Gingival Recession

Keywords

Gingival recession; Non-carious cervical lesion; Connective tissue graft

Outcome Measures

Primary Outcomes (2)

• Recession Reduction

  Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.

  At 12 months

• Complete Root Coverage (CRC)

  Absence or presence of gingival recession at 12 months follow-up.

  At 12 months

Secondary Outcomes (11)

• Root coverage Esthetic Score (RES)

  At 12 months

• Gingival Thickness (GT)

  Baseline - 12 months

• Keratinized Tissue (KT)

  Baseline - 6 and 12 months

• KTgain

  At 12 months

• Gingival Recesión (REC)

  Baseline - 6 and 12 months

Study Arms (2)

CAF

EXPERIMENTAL

After the restoration of the enamel patients were treated with a CAF

Procedure: CAF

CAF + CTG

EXPERIMENTAL

After the restoration of the enamel patients were treated with a CAF + CTG

Procedure: CAF + CTG

Interventions

CAF PROCEDURE

After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession

CAF

CAF + CTG PROCEDURE

After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession

CAF + CTG

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• No systemic diseases or pregnancy.
• Self-reported smoking ≤ 10 cigarettes/day.
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).
• Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.
• Presence of NCCL associated with recession
• No history of mucogingival or periodontal surgery at experimental sites.

You may not qualify if:

• Prosthetic crown at experimental teeth.
• Gingival recessions presenting minimal amount (\< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.

Sponsors & Collaborators

• University of Florence: lead
• University of Roma La Sapienza: collaborator

Related Publications (7)

• Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.

  PMID: 28758301 BACKGROUND

• Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.

  PMID: 27454460 BACKGROUND

• Cairo F, Pini-Prato GP. A technique to identify and reconstruct the cementoenamel junction level using combined periodontal and restorative treatment of gingival recession. A prospective clinical study. Int J Periodontics Restorative Dent. 2010 Dec;30(6):573-81.

  PMID: 20967303 BACKGROUND

• Hwang D, Wang HL. Flap thickness as a predictor of root coverage: a systematic review. J Periodontol. 2006 Oct;77(10):1625-34. doi: 10.1902/jop.2006.060107.

  PMID: 17032103 BACKGROUND

• Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.

  PMID: 19046326 BACKGROUND

• Santamaria MP, da Silva Feitosa D, Nociti FH Jr, Casati MZ, Sallum AW, Sallum EA. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial. J Clin Periodontol. 2009 May;36(5):434-41. doi: 10.1111/j.1600-051X.2009.01389.x.

  PMID: 19419445 BACKGROUND

• Zucchelli G, Gori G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Non-carious cervical lesions associated with gingival recessions: a decision-making process. J Periodontol. 2011 Dec;82(12):1713-24. doi: 10.1902/jop.2011.110080. Epub 2011 May 4.

  PMID: 21542735 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesco Cairo, DDS

  University of Florence

  PRINCIPAL INVESTIGATOR

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: Head, Research Unit in Periodontology and Periodontal Medicine

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: October 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 27, 2025

Record last verified: 2025-03