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

Gingival Recession Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862534
• Other study ID #: RCT restored CEJ
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• CAF
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 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florence	University of Roma La Sapienza

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View Citation

Hwang D, Wang HL. Flap thickness as a predictor of root coverage: a systematic review. J Periodontol. 2006 Oct;77(10):1625-34. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession Reduction	Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.	At 12 months
Primary	Complete Root Coverage (CRC)	Absence or presence of gingival recession at 12 months follow-up.	At 12 months
Secondary	Root coverage Esthetic Score (RES)	Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)	At 12 months
Secondary	Gingival Thickness (GT)	Gingival thickness in mm, measured with an endodontic file and a digital caliper.	Baseline - 12 months
Secondary	Keratinized Tissue (KT)	Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe	Baseline - 6 and 12 months
Secondary	KTgain	Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline	At 12 months
Secondary	Gingival Recesión (REC)	The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe	Baseline - 6 and 12 months
Secondary	Root sensitivity	Toot sensitivity reported by the patient present or absent	Baseline - 6 and 12 months
Secondary	SensVAS	Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.	Baseline - 6 and 12 months
Secondary	SurTime	Surgical Time in minutes from the end of anesthesia to the sutures	At surgery
Secondary	Anti-infammTab	Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.	1 week post-surgery
Secondary	DiscVAS	Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.	1 week post-surgery
Secondary	AesthVAS	Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.	At 12 months