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

NCT ID: NCT03677479

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Socket Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pilot randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
single blinded

Study Groups

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socket preservation with camelline bone

natural hydroxyapatite derived from camels prepared by investigator

Group Type EXPERIMENTAL

socket preservation procedure

Intervention Type PROCEDURE

socket preservation of post extraction site using bone xenografts

socket preservation with bovine bone

natural hydroxyapatite derived from cows (Bio-Oss)

Group Type ACTIVE_COMPARATOR

socket preservation procedure

Intervention Type PROCEDURE

socket preservation of post extraction site using bone xenografts

Interventions

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socket preservation procedure

socket preservation of post extraction site using bone xenografts

Intervention Type PROCEDURE

Other Intervention Names

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alveolar ridge preservation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Adayil

Teaching Assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hosny, PhD

Role: STUDY_CHAIR

Cairo University

Central Contacts

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Ghada Adayil, Msc

Role: CONTACT

(+202)01006010412

References

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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.

Reference Type RESULT
PMID: 30039627 (View on PubMed)

Other Identifiers

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PER123

Identifier Type: -

Identifier Source: org_study_id

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