Role of Hyaluronic Acid in Bone Healing After Dental Extraction

• Sponsor: Damascus University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02330822
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Dental Extraction	Drug: Hyaluronic Acid	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyaluronic Acid Group In this Group, Hyaluronic acid will be injected following extraction.	Drug: Hyaluronic Acid; This material is going to be injected into the extraction socket in order to promote bone healing.
No Intervention: Traditional Extraction Group In this group, traditional extraction procedures will be followed.

Outcome Measures

Primary Outcome Measures

1. Change in bone mineral density (BMD) [(BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.]

   BMD is the amount of bone tissue in a certain volume of bone. This variable is going to be measured on CBCT images.

2. Vertical bone fill [This variable is going to be measured at 6 months post-extraction]

   'Vertical bone fill' is the distance between the base of the extraction socket and cement-enamel junction directly after extraction and minus the distance between base of the extraction socket and cement-enamel junction six months post-extraction. This variable is going to be measured on CBCT images.

Secondary Outcome Measures

1. Buccolingual distance [at six months post-extraction]

   Buccolingual distance is the distance between buccal wall and lingual wall of the extraction socket. This variable is going to be measured clinically.

2. Mesiodistal distance [at six months post-extraction]

   Mesiodistal distance is the distance between mesial wall and distal wall of the extraction socket. This variable is going to be measured clinically.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oral and Maxillofacial Surgery, University of Damascus Dental School	Damascus	Damscus	Syrian Arab Republic	DM20AM18

Sponsors and Collaborators

• Damascus University

Investigators

• Principal Investigator: Sireen Abu Atta, DDS MSc, PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
• Study Director: Mazen Zenati, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Cardaropoli G, Araújo 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.
• de Brito Bezerra B, Mendes Brazão 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.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT02330822
• Other Study ID Numbers: UDDS-OMFS-01-2015
• First Posted: Jan 5, 2015
• Last Update Posted: Sep 29, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

No Results Posted as of Sep 29, 2015