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

• Sponsor: Riyadh Elm University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04851548
• Collaborator: (none)
• Enrollment: 18
• Arms: 2
• Anticipated Duration (Months): 11.9

Study Details

Study Description

Brief Summary

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

Condition or Disease	Intervention/Treatment	Phase
Furcation Defects	Procedure: hyaluronic acid	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acidtest group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement
• Anticipated Study Start Date: Sep 23, 2021
• Anticipated Primary Completion Date: Sep 20, 2022
• Anticipated Study Completion Date: Sep 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. evaluate the regenerative effect of hyaluronic acid [6 months]

   measurement of the bone gain after the treatment with hyaluronic acid in millimeters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Riyadh Elm University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kalra SH, Monga C, Kalra KH, Kalra SH. A roentgenographic assessment of regenerative efficacy of bioactive Gengigel(®) in conjunction with amnion membrane in grade II furcation defect. Contemp Clin Dent. 2015 Apr-Jun;6(2):277-80. doi: 10.4103/0976-237X.156068.
• Sahayata VN, Bhavsar NV, Brahmbhatt NA. An evaluation of 0.2% hyaluronic acid gel (Gengigel ®) in the treatment of gingivitis: a clinical & microbiological study. Oral Health Dent Manag. 2014 Sep;13(3):779-85.

• Responsible Party: Ghady Adnan Alqahtani, periodontic resident, Riyadh Elm University
• ClinicalTrials.gov Identifier: NCT04851548
• Other Study ID Numbers: FPFGRP/2021/566
• First Posted: Apr 20, 2021
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Ghady Adnan Alqahtani, periodontic resident, Riyadh Elm University: Hyaluronic Acid; Furcation involvement
• Additional relevant MeSH terms: Furcation Defects; Hyaluronic Acid

Study Results

No Results Posted as of Sep 17, 2021