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

Not Applicable

• Conditions: Furcation Defects
• Interventions: Procedure: hyaluronic acid

• Registration Number: NCT04851548
• Lead Sponsor: Riyadh Elm University

Brief Summary

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

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 Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-17
• Study Start: 2021-09-23
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (control)	hyaluronic acid	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\|)
Group B (test)	hyaluronic acid	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\|).

Primary Outcome Measures

Name	Time	Method
evaluate the regenerative effect of hyaluronic acid	6 months	measurement of the bone gain after the treatment with hyaluronic acid in millimeters