Evaluate the Effect of Hyaluronic Acid in the Treatment of Furcation Involvement

September 15, 2021 updated by: Ghady Adnan Alqahtani, Riyadh Elm University

Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The materials to be used in the study are the following:

  • Hyaluronic acid
  • Cone-beam computed tomography(CBCT) x-ray The patients with Grade II furcation will be divided into two groups. Both groups will have the same number of patients and the same procedure, such as the scaling root planning. However, the control group will use hyaluronic acid and membrane. The placebo group, on the other hand, will use hyaluronic acid without membrane and will use CBCT x-ray. The x-rays will be done at the beginning of the treatment. Then, two monitoring processes will be done. The first monitor will be done after three months. The data will be recorded. Then, after another three months, the patients will undergo an x-ray check again, and the data will be recorded. The goal is only to have the patients exposed to x-ray twice so they would not be compromised to the high dose of radiation. The evaluation to be done for the 3-month interval will only be clinical assessments.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Selected teeth: Permanent first and second molars in the mandible.
  2. Furcation dimension: Radiographic and clinical evidence of exhibiting defects due to Grade II furcation with at least 2 millimeters probing depth horizontally and at least 5 millimeters probing depth circumferential.
  3. Gender: both males and females.
  4. Age range: between 18 and 55 years.
  5. Health status: healthy patients non-systemic diseased except controlled diabetic.
  6. Compliance: Patients will be willing and able to comply with adequate oral hygiene protocols.

Exclusion Criteria:

  1. Patients that received periodontal regenerative therapy within the past 12 months.
  2. Patients that are lactating.
  3. Pregnant patients.
  4. Smokers.
  5. Patients with pulp infection.
  6. Patients with trauma resulting from occlusion.
  7. Patients with receding gum.
  8. Patients with tooth mobility greater than grade II.
  9. Patients that will not comply with the hygiene protocols in Phase I therapy.
  10. Patients with potential illnesses that can influence the periodontal therapy outcomes.
  11. Patients that are taking medications that can interfere with the healing outcomes of the periodontal wound.
  12. Patients allergic to any drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (control)

preoperative cone-beam computed tomography (CBCT) scans N=9

  • open flap debridement.
  • use membrane without hyaluronic acid. (The first monitor will be done after three months. The data will be recorded. After another three months, the patients will undergo an x-ray check again, and the data will be registered. The goal is to have the patients exposed to x-ray twice not to be compromised to a high radiation dose. The evaluation to be done for the 3-month interval will only be clinical assessments|)
Procedure: hyaluronic acid
after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane
Active Comparator: Group B (test)

preoperative cone-beam computed tomography (CBCT )scans N= 9

  • open flap debridement.
  • use membrane and 8% hyaluronic acid gel (The first monitor will be done after three months. The data will be recorded. After another three months, the patients will undergo an x-ray check again, and the data will be registered. The goal is to have the patients exposed to x-ray twice not to be compromised to a high radiation dose. The evaluation to be done for the 3-month interval will only be clinical assessments|).
Procedure: hyaluronic acid
after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the regenerative effect of hyaluronic acid
Time Frame: 6 months
measurement of the bone gain after the treatment with hyaluronic acid in millimeters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Elm University

Investigators

  • Study Director: ahmed t gamal, clinical MD, Riyadh Elm University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 23, 2021

Primary Completion (Anticipated)

September 20, 2022

Study Completion (Anticipated)

September 20, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

April 18, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPFGRP/2021/566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Furcation Defects

Clinical Trials on hyaluronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe