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

Gingival Recession Clinical Trial

Official title:

Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460182
• Other study ID #: RT2-10
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2022
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Other:
• CAF+CTG
Coronally Advanced Flap + Connective Tissue Graft
• CAF
Coronally Advanced Flap

Locations

Country	Name	City	State
Italy	University of Florence	Florence	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Root Coverage (CRC)	Complete Root Coverage: absence of gingival recession (Yes/No)	After the intervention (10 years)
Secondary	Recession Reduction (RecRed)	Change of the gingival recession, in mm	After the intervention (10 years)
Secondary	Root Coverage Aesthetic Score (RES)	A scoring system ranging from 0 to 10	After the intervention (10 years)