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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03862534
Enrollment
30
Registered
2019-03-05
Start date
2014-10-31
Completion date
2018-12-31
Last updated
2025-03-27

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

Conditions

Gingival Recession

Keywords

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

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).

Interventions

PROCEDURECAF

After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession

PROCEDURECAF + CTG

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

Sponsors

University of Roma La Sapienza
CollaboratorOTHER
University of Florence
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recession ReductionAt 12 monthsDifference between gingival recession at 12 months and baseline, measured with a periodontal probe.
Complete Root Coverage (CRC)At 12 monthsAbsence or presence of gingival recession at 12 months follow-up.

Secondary

MeasureTime frameDescription
Keratinized Tissue (KT)Baseline - 6 and 12 monthsWidth of the keratinized gingiva measured in mm from the gingival margin to the muco-gingival-junction using a periodontal probe
KTgainAt 12 monthsGain of Keratinized Tissue measured as the difference between KT at 12 months and KT baseline
Gingival Recesión (REC)Baseline - 6 and 12 monthsThe distance between the reconstructed cementum enamel junction and the gingival margin measured in mm with a periodontal probe
Root sensitivityBaseline - 6 and 12 monthsToot sensitivity reported by the patient present or absent
Root coverage Esthetic Score (RES)At 12 monthsOverall esthetic score from 0 to 10 evaluated by the blinded examiner. Higher values represent a better outcome. (Pini-Prato et al. 2011)
SurTimeAt surgerySurgical Time in minutes from the end of anesthesia to the sutures
Anti-infammTab1 week post-surgeryNumber of tablets of anti-inflammatory drug taken in the first week post-operatively by the patients.
DiscVAS1 week post-surgeryPost Operative Discomfort reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.
AesthVASAt 12 monthsAesthetic overall satisfaction reported by the patients on a 0 to 10 Visual Analogue Scale. Higher values represent better outcomes.
SensVASBaseline - 6 and 12 monthsToot sensitivity reported by the patient on a 0 to 10 Visual Analogue Scale. Higher values represent worse outcome.
Gingival Thickness (GT)Baseline - 12 monthsGingival thickness in mm, measured with an endodontic file and a digital caliper.

Outcome results

None listed

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