Clinical trial NCT02330822: Role of Hyaluronic Acid in Bone Healing After Dental Extraction
Official title: A Clinical and Experimental Study to Evaluate the Efficacy of Locally Applied Hyaluronic Acid in Bone Healing Following Dental Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Dental Extraction
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in bone mineral density (BMD)
timeFrame: (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.
measure: Vertical bone fill
timeFrame: This variable is going to be measured at 6 months post-extraction
Secondary outcomes:
measure: Buccolingual distance
timeFrame: at six months post-extraction
measure: Mesiodistal distance
timeFrame: at six months post-extraction
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
state: Damscus
Study officials:
affiliation: PhD student, Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
name: Sireen Abu Atta, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Oral and Maxillofacial Surgery, University of Damsacus Dental School
name: Mazen Zenati, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.