Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft

Early Phase 1

• Conditions: Socket Preservation
• Interventions: Procedure: socket preservation procedure

• Registration Number: NCT03677479
• Lead Sponsor: Cairo University

Brief Summary

Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge.

To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.

Detailed Description

Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Study Start: 2019-03
• Primary Completion: 2020-02
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction.
• Healthy non-smoker patients

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Exclusion Criteria

• Medically compromised patients.
• Pregnant females.
• History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years.
• History of active bone metabolic disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
socket preservation with camelline bone	socket preservation procedure	natural hydroxyapatite derived from camels prepared by investigator
socket preservation with bovine bone	socket preservation procedure	natural hydroxyapatite derived from cows (Bio-Oss)

Primary Outcome Measures

Name	Time	Method
patient-reported outcome	within first week postoperatively	assessment of post-operative complication( pain, swelling, bleeding, infection)

Secondary Outcome Measures

Name	Time	Method
ridge contour changes	3 month, 6 month	dimentional changes after extraction and socket preservation