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

NCT ID: NCT03862534

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CAF

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

Group Type EXPERIMENTAL

CAF

Intervention Type PROCEDURE

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

CAF + CTG

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

Group Type EXPERIMENTAL

CAF + CTG

Intervention Type 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

Interventions

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CAF

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

Intervention Type PROCEDURE

CAF + CTG

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Dr. Francesco Cairo

Head, Research Unit in Periodontology and Periodontal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Cairo, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Florence

References

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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.

Reference Type BACKGROUND
PMID: 28758301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27454460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20967303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17032103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19046326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19419445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21542735 (View on PubMed)

Other Identifiers

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RCT restored CEJ

Identifier Type: -

Identifier Source: org_study_id

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