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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: CAF; Procedure: CAF + CTG

• Registration Number: NCT03862534
• Lead Sponsor: University of Florence

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2017-09
• Study Completion: 2018-12
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Recession Reduction	At 12 months	Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.
Complete Root Coverage (CRC)	At 12 months	Absence or presence of gingival recession at 12 months follow-up.

Secondary Outcome Measures

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