Edentulous Sites Augmented With Collagen Matrix or CTG

Not Applicable

Recruiting

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG); Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix

• Registration Number: NCT04915677
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Study Start: 2021-06-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-06-10
• Study Completion: 2024-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subepithelial Connective Tissue Graft (SCTG)	Soft tissue augmentation with subepithelial connective tissue graft (SCTG)	Soft tissue augmentation at edentulous area with subepithelial connective tissue graft harvested from the patient's palate
Volume Stable Collagen Matrix (VCMX)	Soft tissue augmentation with xenogenic volume stable collagen matrix	Soft tissue augmentation at edentulous area with xenogenic volume stable collagen matrix

Primary Outcome Measures

Name	Time	Method
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)	6 months	Mean linear change in mm from baseline to 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	2 weeks	Subjective pain experienced by the patient expressed in a VAS scale
Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)	6 months	The distance between the cementoenamel junction (CEJ) and the mucosal margin
Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)	6 months	The distance between cementoenamel junction (CEJ) and the base of the pocket

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, Italy