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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CAF

CAF + CTG

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival recession, Non-carious cervical lesion, Connective tissue graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CAF

CAF + CTG

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recession Reduction

Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.

Complete Root Coverage (CRC)

Absence or presence of gingival recession at 12 months follow-up.

Secondary Outcome Measures

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)

Gingival Thickness (GT)

Gingival thickness in mm, measured with an endodontic file and a digital caliper.

Keratinized Tissue (KT)

Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe

KTgain

Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline

Gingival Recesión (REC)

The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe

Root sensitivity

Toot sensitivity reported by the patient present or absent

SensVAS

Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

SurTime

Surgical Time in minutes from the end of anesthesia to the sutures

Anti-infammTab

Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.

DiscVAS

Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

AesthVAS

Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.

Full Information

NCT ID

NCT03862534

First Posted

February 27, 2019

Last Updated

September 9, 2019

Sponsor

University of Florence

Collaborators

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT03862534

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Florence

Collaborators

University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

Gingival recession, Non-carious cervical lesion, Connective tissue graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAF

Arm Type

Experimental

Arm Description

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

Arm Title

CAF + CTG

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

CAF

Intervention Description

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

Intervention Name(s)

CAF + CTG

Intervention Description

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

Primary Outcome Measure Information:

Title

Recession Reduction

Description

Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.

Time Frame

At 12 months

Title

Complete Root Coverage (CRC)

Description

Absence or presence of gingival recession at 12 months follow-up.

Time Frame

At 12 months

Secondary Outcome Measure Information:

Title

Root coverage Esthetic Score (RES)

Description

Overall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)

Time Frame

At 12 months

Title

Gingival Thickness (GT)

Description

Gingival thickness in mm, measured with an endodontic file and a digital caliper.

Time Frame

Baseline - 12 months

Title

Keratinized Tissue (KT)

Description

Width of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe

Time Frame

Baseline - 6 and 12 months

Title

KTgain

Description

Gain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline

Time Frame

At 12 months

Title

Gingival Recesión (REC)

Description

The distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe

Time Frame

Baseline - 6 and 12 months

Title

Root sensitivity

Description

Toot sensitivity reported by the patient present or absent

Time Frame

Baseline - 6 and 12 months

Title

SensVAS

Description

Toot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

Time Frame

Baseline - 6 and 12 months

Title

SurTime

Description

Surgical Time in minutes from the end of anesthesia to the sutures

Time Frame

At surgery

Title

Anti-infammTab

Description

Number of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.

Time Frame

1 week post-surgery

Title

DiscVAS

Description

Post Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.

Time Frame

1 week post-surgery

Title

AesthVAS

Description

Aesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.

Time Frame

At 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco Cairo, DDS

Organizational Affiliation

University of Florence

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

28758301

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.

Results Reference

background

PubMed Identifier

27454460

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.

Results Reference

background

PubMed Identifier

20967303

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.

Results Reference

background

PubMed Identifier

17032103

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.

Results Reference

background

PubMed Identifier

19046326

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.

Results Reference

background

PubMed Identifier

19419445

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.

Results Reference

background

PubMed Identifier

21542735

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.

Results Reference

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

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