Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences

Dental Implants Clinical Trial

Official title:

Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Volume-stable Collagen Matrix or Connective Tissue Graft: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466006
• Other study ID #: GFGTurin2
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of Turin, Italy
• Contact: Mario Aimetti
• Phone: 00390116331546
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

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

Locations

Country	Name	City	State
Italy	University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Primary	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	12 months
Primary	Pain (VAS scale)(0-10 with higher values indicating worse outcomes)	Subjective pain experienced by the patient expressed in a VAS scale	12 months
Primary	Bleeding on probing (0 no bleeding, 1 presence of bleeding)	Bleeding after probing within 15 seconds	12 months