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

NCT04338139 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-04-10

No results posted yet for this study

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

Interventions

PROCEDURE

bone regeneration

bone regeneration using bio-oss collagen

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-12-30
Completion
2021-07-30

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338139 on ClinicalTrials.gov