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

September 9, 2019 updated by: Dr. Francesco Cairo, University of Florence

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAF
After the restoration of the enamel patients were treated with a CAF
Procedure: CAF
After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession
Experimental: CAF + CTG
After the restoration of the enamel patients were treated with a CAF + CTG
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Collaborators

University of Roma La Sapienza

Investigators

  • Principal Investigator: Francesco Cairo, DDS, University of Florence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

March 2, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT restored CEJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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