Clinical trial NCT03862534: CAF With or Without CTG for the Treatment of Single Maxillary Gingival Recession With NCCL
Official title: Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival recession
Non-carious cervical lesion
Connective tissue graft
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2019-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Recession Reduction
timeFrame: At 12 months
measure: Complete Root Coverage (CRC)
timeFrame: At 12 months
Secondary outcomes:
measure: Root coverage Esthetic Score (RES)
timeFrame: At 12 months
measure: Gingival Thickness (GT)
timeFrame: Baseline - 12 months
measure: Keratinized Tissue (KT)
timeFrame: Baseline - 6 and 12 months
measure: KTgain
timeFrame: At 12 months
measure: Gingival Recesión (REC)
timeFrame: Baseline - 6 and 12 months
measure: Root sensitivity
timeFrame: Baseline - 6 and 12 months
measure: SensVAS
timeFrame: Baseline - 6 and 12 months
measure: SurTime
timeFrame: At surgery
measure: Anti-infammTab
timeFrame: 1 week post-surgery
measure: DiscVAS
timeFrame: 1 week post-surgery
measure: AesthVAS
timeFrame: At 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Florence
name: Francesco Cairo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.