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

Not Applicable

Not yet recruiting

• Conditions: Guided Bone Regeneration
• Interventions: Procedure: Guided Bone regeneration

• Registration Number: NCT06257225
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Study Start: 2024-02-15
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient showing horizontal defect and treated with GBR stabilized with Tacs	Guided Bone regeneration	Fixation
Patient showing horizontal defect and treated with GBR stabilized with no Tacs	Guided Bone regeneration	No Fixation

Primary Outcome Measures

Name	Time	Method
Horizontal bone gain assessed radiographically (mm)	Baseline , 4 month	Using CBCT

Secondary Outcome Measures

Name	Time	Method
Horizontal bone gain assessed clinically (mm)	Baseline , 4 month	Bone Caliper
Surgical Time	During Surgery	Stop Watch
Amount of Pain	7 days	Number of analgesics consumed daily for 7 days
Histological Evaluation	4 month	Core Biopsy
Patient satisfaction	4 month	Questionnaire - Binary