NCT02330822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

January 1, 2015

Last Update Submit

September 26, 2015

Conditions

Patients With Dental Extraction

Outcome Measures

Primary Outcomes (2)

  • Change in bone mineral density (BMD)

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

    (BMD) will be measured two times in this study: directly at the day of extraction and six months post-extraction.

  • Vertical bone fill

    '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.

    This variable is going to be measured at 6 months post-extraction

Secondary Outcomes (2)

  • Buccolingual distance

    at six months post-extraction

  • Mesiodistal distance

    at six months post-extraction

Study Arms (2)

Hyaluronic Acid Group

EXPERIMENTAL

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

Drug: Hyaluronic Acid

Traditional Extraction Group

NO INTERVENTION

In this group, traditional extraction procedures will be followed.

Interventions

Hyaluronic AcidDRUG

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

Hyaluronic Acid Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Symmetric teeth requiring extraction in the lower jaw
  • Systematically healthy

You may not qualify if:

  • Smokers
  • Pregnancy (for female participants)
  • Diabetic patients
  • Patients with metabolic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Damascus, Damscus, DM20AM18, Syria

Location

Related Publications (3)

  • 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.

    PMID: 22238698BACKGROUND

  • 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.

    PMID: 15842256BACKGROUND

  • 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.

    PMID: 21689163BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Sireen Abu Atta, DDS MSc

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

    PRINCIPAL INVESTIGATOR

  • Mazen Zenati, DDS MSc PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2015

First Posted

January 5, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

SY(1)