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Connective Tissue Graft Versus Collagen Matrix.

NCT04678804 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-17

No results posted yet for this study

Summary

Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on recession coverage percentage, without taking into account the changes in tissue thickness and biotype in the surgical area. Hence, this study aims to compare threedimensional scans of gingival recessions treated either with CAF+CTG or with CAF+PDCM by the use of a dedicated superimposition software at different healing timepoints.

The primary outcome is to assess the change in mm3 and the distribution pattern of soft tissue thickening in the surgical area between autologous and heterologous grafts at 1, 3, and 6 months post-surgery. The secondary outcomes are: the complete root coverage at 6 months post surgery and Patients' Reported Outcomes (PROMS) measured with oral impact on daily performances (OIDP questionnaire) and on the evaluation of patients' perception about therapy.

Conditions

  • Gingival Diseases

Interventions

PROCEDURE

Mucogingival surgery for single recession coverage

The control group will be treated with a coronally advanced flap with vertical incisions (CAF) associated to an autologous connective tissue graft. The graft will be harvested from the palate in the area apical to the gingival margin of the second molar with an epithelial-connective harvesting technique to obtain a connective graft of 1 mm in thickness. Subsequently, the graft will be shaped in order to match height and width of the recipient site on the recession according to the technique proposed by Zucchelli in 2003. The test group will receive the same flap design with the same technique, then the porcine derived xenogeneic graft will be shaped in order to match height and width of the recipient site on the recession. In particular, the matrix will be reduced in thickness as suggested by the manufacturer to obtain a standardized thickness of 3 mm.

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Elena Calciolari, DDS · Researcher

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2022-11-02
Completion
2023-05-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678804 on ClinicalTrials.gov