Edentulous Sites Augmented With Collagen Matrix or CTG

University of Turin

Status: Enrolling

Conditions: Edentulous Alveolar Ridge

Treatments: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG); Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT04915677

GFGTurin1

Details and patient eligibility

About

Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
• At least 18 years old
• At least 6 months from tooth extraction at the study area.

Exclusion criteria

• Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
• Smoking ≥ 10 cigarettes a day;
• Pregnant or nursing women;
• Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
• Patients who need use of medications affecting bone metabolism or oral mucosa;
• Presence of a congruous FDP at the edentulous area;
• History of soft tissue augmentation surgery in the study area;
• Active periodontitis
• Uncompliant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Subepithelial Connective Tissue Graft (SCTG)

Active Comparator group

Description:

Soft tissue augmentation at edentulous area with subepithelial connective tissue graft harvested from the patient's palate

Treatment:

Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Volume Stable Collagen Matrix (VCMX)

Experimental group

Description:

Soft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix

Treatment:

Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix