Clinical trial NCT04338139: Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration
Official title: Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Regeneration
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations
timeFrame: 1 year
Secondary outcomes:
measure: linear measurements of the amount of grafted bone resorption
timeFrame: 1 year
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph University
Study officials:
References: