Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration

NCT04338139 | Unknown

• 1 other identifier: USJ-2019-112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:

• Pre-operatively:
• cone beam computed tomography CBCT
• 1 minute mouthwash with a 0.12% Chlorhexidine solution
• Full thickness muco-periosteal flap and ridge curettage.
• Drilling and implant placement (any implant system)
• Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
• Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.
• Post-operatively:
• Medication:
• Amoxicilline (1g) or Clindamycine (300mg)
• Analgesic, (paracetamol + codeine)
• Mouthwash with a solution of 0.12% Chlorhexidine
• cone beam computed tomography CBCT
• 4 months postoperatively: CBCT Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique

Conditions

Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations

  cbct radiographic measurements

  1 year

Secondary Outcomes (1)

• linear measurements of the amount of grafted bone resorption

  1 year

Study Arms (1)

Bio-oss Collagen

EXPERIMENTAL

90% xengeneic bovine bone partciles + 10% collagen type I

Procedure: bone regeneration

Interventions

bone regeneration PROCEDURE

bone regeneration using bio-oss collagen

Bio-oss Collagen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18 years old
• Smoking \<10 cigarettes/day (Light smoker)
• Good general health.
• Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.

You may not qualify if:

• A pregnant or nursing mother
• Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.
• Orthodontic treatment in progress or planned
• \- Adjacent risk teeth

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University

Beirut, 1104 2020, Lebanon

Location

MeSH Terms

Interventions

Bone Regeneration

Intervention Hierarchy (Ancestors)

Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 8, 2020
• Study Start: January 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: July 30, 2021
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year
• Access Criteria: article publication

Locations

LE (1)