Role of Hyaluronic Acid in Bone Healing After Dental Extraction

NCT ID: NCT02330822

Last Updated: 2015-09-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-09-30

Brief Summary

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This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.

Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.

cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.

Detailed Description

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I- Clinical examination variables:

Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.

II- Radiographic examination variables:

Linear measurements Vertical bone fill Bone mineral density

Conditions

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Patients With Dental Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyaluronic Acid Group

In this Group, Hyaluronic acid will be injected following extraction.

Group Type EXPERIMENTAL

Hyaluronic Acid

Intervention Type DRUG

This material is going to be injected into the extraction socket in order to promote bone healing.

Traditional Extraction Group

In this group, traditional extraction procedures will be followed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyaluronic Acid

This material is going to be injected into the extraction socket in order to promote bone healing.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-60 years old
* Symmetric teeth requiring extraction in the lower jaw
* Systematically healthy

Exclusion Criteria

* Smokers
* Pregnancy (for female participants)
* Diabetic patients
* Patients with metabolic problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sireen Abu Atta, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Mazen Zenati, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School

Locations

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Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Damascus, Damscus, Syria

Site Status

Countries

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Syria

References

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Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.

Reference Type BACKGROUND
PMID: 22238698 (View on PubMed)

Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.

Reference Type BACKGROUND
PMID: 15842256 (View on PubMed)

de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.

Reference Type BACKGROUND
PMID: 21689163 (View on PubMed)

Other Identifiers

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UDDS-OMFS-01-2015

Identifier Type: -

Identifier Source: org_study_id

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