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

Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Socket Preservation
• Intervention / Treatment: Procedure: socket preservation procedure

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ghada Adayil, Msc; Phone Number: (+202)01006010412; Email: ghada.adayil@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: socket preservation with camelline bone; natural hydroxyapatite derived from camels prepared by investigator	Procedure: socket preservation procedure; socket preservation of post extraction site using bone xenografts; Other Names: alveolar ridge preservation
Active Comparator: socket preservation with bovine bone; natural hydroxyapatite derived from cows (Bio-Oss)	Procedure: socket preservation procedure; socket preservation of post extraction site using bone xenografts; Other Names: alveolar ridge preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-reported outcome	assessment of post-operative complication( pain, swelling, bleeding, infection)	within first week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ridge contour changes	dimentional changes after extraction and socket preservation	3 month, 6 month

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Chang PC, Chang HC, Lin TC, Tai WC. Preclinical alveolar ridge preservation using small-sized particles of bone replacement graft in combination with a gelatin cryogel scaffold. J Periodontol. 2018 Oct;89(10):1221-1229. doi: 10.1002/JPER.17-0629. Epub 2018 Aug 29.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: xenograft; bone grafts
• Other Study ID Numbers: PER123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: check with university guidelines for raw data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No