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Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial

NCT ID: NCT05460182

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-03-01

Brief Summary

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Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Two examiners, blinded with respect to the surgical procedures, assessed all the clinical and aesthetic outcomes of treatments.

Study Groups

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CAF+CTG

After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed.

A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured

Group Type EXPERIMENTAL

CAF+CTG

Intervention Type OTHER

Coronally Advanced Flap + Connective Tissue Graft

CAF

After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured

Group Type ACTIVE_COMPARATOR

CAF

Intervention Type OTHER

Coronally Advanced Flap

Interventions

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CAF+CTG

Coronally Advanced Flap + Connective Tissue Graft

Intervention Type OTHER

CAF

Coronally Advanced Flap

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Smoking \< 20 cigarettes/day.
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 15% (measured at four sites per tooth).
* Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession \> 2 mm of depth
* Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
* Presence of an identifiable CEJ

Exclusion Criteria

* Systemic diseases or pregnancy.
* Systemic antibiotic therapy in the last 6 months.
* Active periodontal disease with sites showing probing depth \>4 mm.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Dr. Francesco Cairo

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Florence

Florence, Tuscany, Italy

Site Status

Countries

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Italy

References

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Cairo F, Cortellini P, Barbato L, Masseti L, Mervelt J, Nieri M, Pini Prato GP, Tonetti MS. Long-term comparison of root coverage procedures at single RT2 maxillary gingival recessions: Ten-year extension results from a randomized, controlled clinical trial. J Clin Periodontol. 2023 Apr;50(4):511-519. doi: 10.1111/jcpe.13778. Epub 2023 Jan 24.

Reference Type DERIVED
PMID: 36644804 (View on PubMed)

Other Identifiers

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RT2-10

Identifier Type: -

Identifier Source: org_study_id