Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

University of Turin, Italy28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dental Implants

Interventions

Soft tissue augmentation with subepithelial connective tissue graft (SCTG)PROCEDURE

After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), SCTG will be harvested from the palate and sutured to the flap. Simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.

Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)PROCEDURE

After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), VCMX will be sutured to the flap and simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Turin

Turin, Italy

RECRUITING

Outcomes

Primary Outcomes

Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)

Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin

Time frame: 12 months

Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)

The distance between the buccal soft tissue margin and the base of the pocket

Time frame: 12 months

Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)

The distance between the crown margin and the mucosal margin

Time frame: 12 months

Pain (VAS scale)(0-10 with higher values indicating worse outcomes)

Subjective pain experienced by the patient expressed in a VAS scale

Time frame: 12 months

Bleeding on probing (0 no bleeding, 1 presence of bleeding)

Bleeding after probing within 15 seconds

Time frame: 12 months

Central Contacts

Mario Aimetti

CONTACT

00390116331546 mario.aimetti@unito.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.