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

NCT05460182 | Completed

• 1 other identifier: RT2-10
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Complete Root Coverage (CRC)

  Complete Root Coverage: absence of gingival recession (Yes/No)

  After the intervention (10 years)

Secondary Outcomes (2)

• Recession Reduction (RecRed)

  After the intervention (10 years)

• Root Coverage Aesthetic Score (RES)

  After the intervention (10 years)

Study Arms (2)

CAF+CTG

EXPERIMENTAL

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

Other: CAF+CTG

CAF

ACTIVE COMPARATOR

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

Other: CAF

Interventions

CAF+CTG OTHER

Coronally Advanced Flap + Connective Tissue Graft

CAF+CTG

CAF OTHER

Coronally Advanced Flap

CAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

University of Florence

Florence, Tuscany, 50100, Italy

Location

Related Publications (1)

• 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.

  PMID: 36644804 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two examiners, blinded with respect to the surgical procedures, assessed all the clinical and aesthetic outcomes of treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

IT (1)