The Influence of Non-Carious Cervical Lesions on Root Coverage
NCT ID: NCT06438094
Last Updated: 2024-06-04
Study Results
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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RECRUITING
NA
56 participants
INTERVENTIONAL
2024-05-26
2026-05-25
Brief Summary
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In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Type A gingival recession defects
Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only.
Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
Type B gingival recession defects
Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery.
Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
Interventions
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Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft
Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate.
Eligibility Criteria
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Inclusion Criteria
* Healthy periodontal status according to the AAP/EFP definition;
* Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%;
* At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL;
* No history of periodontal surgery at the experimental site(s).
Exclusion Criteria
* Self-reported smoking ≥10 cigarettes/day;
* Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);
* Any medication that may interfere with wound healing;
* Prosthetic crown at experimental teeth;
* Ongoing orthodontic therapy.
18 Years
ALL
Yes
Sponsors
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Gonzalo Blasi
OTHER
Responsible Party
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Gonzalo Blasi
Clinical professor
Principal Investigators
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Gonzalo Blasi
Role: STUDY_DIRECTOR
Universitat Internacional de Catalunya
José Nart
Role: PRINCIPAL_INVESTIGATOR
Universitat Internacional de Catalunya
Locations
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BLASI Clínica Dental Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PER-ECL-2022-01
Identifier Type: -
Identifier Source: org_study_id
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