Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

Not Applicable

Recruiting

• Conditions: Dental Implants
• Interventions: Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM); Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

• Registration Number: NCT05466006
• Lead Sponsor: University of Turin, Italy

Brief Summary

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (\<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-16
• Study First Posted: 2022-07-20
• Study Start: 2022-09-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

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

Inclusion Criteria

• Single tooth edentulous space
• Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT
• Completed non-surgical periodontal therapy (if needed)
• FMPS and FMBS < 20%

Exclusion Criteria

• Age < 18 years old
• Pregnancy or lactation
• Heavy smokers (> 10 cigarette/day)
• Conditions or diseases contraindicating surgical interventions
• Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement
• Need for bone regeneration at the implant site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volume Stable Collagen Matrix (VCMX)	Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)	Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix
Subepithelial Connective Tissue Graft (SCTG)	Soft tissue augmentation with subepithelial connective tissue graft (SCTG)	Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate

Primary Outcome Measures

Name	Time	Method
Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	12 months	Subjective pain experienced by the patient expressed in a VAS scale
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)	12 months	Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin
Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)	12 months	The distance between the crown margin and the mucosal margin
Bleeding on probing (0 no bleeding, 1 presence of bleeding)	12 months	Bleeding after probing within 15 seconds
Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)	12 months	The distance between the buccal soft tissue margin and the base of the pocket

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, Italy