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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05460182
Enrollment
29
Registered
2022-07-15
Start date
2021-08-01
Completion date
2022-03-01
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

OTHERCAF+CTG

Coronally Advanced Flap + Connective Tissue Graft

OTHERCAF

Coronally Advanced Flap

Sponsors

University of Florence
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complete Root Coverage (CRC)After the intervention (10 years)Complete Root Coverage: absence of gingival recession (Yes/No)

Secondary

MeasureTime frameDescription
Recession Reduction (RecRed)After the intervention (10 years)Change of the gingival recession, in mm
Root Coverage Aesthetic Score (RES)After the intervention (10 years)A scoring system ranging from 0 to 10

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026