Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs

NCT06257225 | Not Yet Recruiting DMC

• 1 other identifier: PerioMIU1029
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization

Conditions

Guided Bone Regeneration

Keywords

GBR; Tacs

Outcome Measures

Primary Outcomes (1)

• Horizontal bone gain assessed radiographically (mm)

  Using CBCT

  Baseline , 4 month

Secondary Outcomes (6)

• Horizontal bone gain assessed clinically (mm)

  Baseline , 4 month

• Amount of Pain

  7 days

• Amount of Pain

  7 days

• Patient satisfaction

  4 month

• Surgical Time

  During Surgery

Study Arms (2)

Patient showing horizontal defect and treated with GBR stabilized with Tacs

ACTIVE COMPARATOR

Fixation

Procedure: Guided Bone regeneration

Patient showing horizontal defect and treated with GBR stabilized with no Tacs

EXPERIMENTAL

No Fixation

Procedure: Guided Bone regeneration

Interventions

Guided Bone regeneration PROCEDURE

After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks

Patient showing horizontal defect and treated with GBR stabilized with Tacs; Patient showing horizontal defect and treated with GBR stabilized with no Tacs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients
• Healed alveolar ridge for implant placement with:
• Deficient buccolingual dimension ( ≤5mm)
• Sufficient vertical height (≥ 10 mm)
• Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen

You may not qualify if:

• Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest

Sponsors & Collaborators

• Cairo University: lead
• Misr International University: collaborator

MeSH Terms

Conditions

Spondylocostal Dysostosis 4, Autosomal Dominant

Study Officials

• Hani ElNahass, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Omnia Tawfik, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Yahya Amer, PhD

CONTACT

+201006194329; yahia.hassan@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontology

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 15, 2024
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02