Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)

Last updated: February 28, 2024
Sponsor: Prince of Songkla University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Density

Treatment

Ridge augmentation with semi-rigid shell barrier system

Clinical Study ID

NCT06295055
Dentistry Prince of Songkla
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study aims to compare the clinical outcome before and after augmentation in case series of 10 patients. The main question it aims to answer is Whether the semi-rigid shell system facilitates bone regeneration in moderate to severe alveolar bone defects after 4 months of bone augmentation. Participants with bone defects between 3 to 8 millimeters (moderate to severe bone defect) will be treated with xenograft covered with the semi-rigid shell barrier system as a stage approach technique for implant placement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bonedefect) covered 1-2 tooth span with adjacent tooth
  • Planned for dental implant and fixed prosthesis
  • Aged 20 and above but under the age of 65 with good physical health and good oralhygiene
  • Able to comprehend and are willing to sign the consent form and can adhere to theprotocol including scheduled clinic visits and assigned treatment.
  • Available for follow-up after implant placement.

Exclusion

Exclusion Criteria:

  • (i) Heavy smokers (>10 cigarettes/day)
  • (ii) receiving bisphosphonates
  • (iii) undergoing radiotherapy
  • (iv) uncontrolled medical conditions
  • (v) Alcoholism
  • (vi) Pregnancy.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Ridge augmentation with semi-rigid shell barrier system
Phase:
Study Start date:
January 04, 2024
Estimated Completion Date:
June 30, 2025

Study Description

Inclusion criteria are subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth, planned for dental implant and fixed prosthesis, aged 20 and above but under the age of 65 with good physical health and good oral hygiene, able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment and available for follow-up after implant placement.

Exclusion criteria are subjects in following reasons: (i) Heavy smokers (>10 cigarettes/day), (ii) receiving bisphosphonates, (iii) undergoing radiotherapy, (iv) uncontrolled medical conditions, (v) Alcoholism, (vi) Pregnancy Bone augmentation procedure Before surgery, patients will be premedication with 1000 mg of amoxicillin antibiotic and rinse chlorhexidine mouthwash 0.12% concentration for 1 minute. A single oral and maxillofacial surgeon will perform all surgical procedures. Local anesthesia with 4% Articaine hydrochloride with epinephrine 1: 100,000 (Septanest, Septodont, France) will be administered to each patient for inferior alveolar nerve block or local infiltration. A full thickness mucoperiosteal flap will be created, and the actual defect size will be measured with a periodontal probe following the flap procedure. Flap advancement with periosteal releasing flap, decorticate the bone with a round bur, then apply the semi-rigid shell and fix it with ti-tacks or screws. Following that, xenograft, a bone graft material will be placed, and ti-tacks will be used to fix the semi-resorbable covering membrane. Lastly, tension-free flap closure with double layer suturing technique which is a horizontal mattress and interrupts suture.

Connect with a study center

  • Prince of Songkla

    Songkhla, Hatyai 90110
    Thailand

    Active - Recruiting

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