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

Furcation Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04851548
• Other study ID #: FPFGRP/2021/566
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: September 2021
• Source: Riyadh Elm University
• Contact: ghady m alqhtani, BDS
• Phone: 00966541719298
• Email: ghadi.a.alqahtani2019[@]student.riyadh.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Procedure:
• hyaluronic acid
after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Elm University

References & Publications (11)

Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35. — View Citation

Björn H, Halling A, Thyberg H. Radiographic assessment of marginal bone loss. Odontol Revy. 1969;20(2):165-79. — View Citation

Carranza, F. A. & Newman, M. G., 2018. Clinical Periodontology. USA: WB Saunders & Co.

Gaurav Bakutra., et al. "Prevalence, Extension and Severity Associated Risk Factors Associated with Furcation Involvement in an Adult Population. An Epidemiological Study

Glickman, I. (1972). Clinical Periodontology: Prevention, Diagnosis, and Treatment of Periodontal Disease in the Practice of General Dentistry (4th ed.). Saunder.

https://doi.org/10.1902/jop.1959.30.1.7

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. — View Citation

Pilloni A, Rojas MA. Furcation Involvement Classification: A Comprehensive Review and a New System Proposal. Dent J (Basel). 2018 Jul 23;6(3). pii: E34. doi: 10.3390/dj6030034. Review. — View Citation

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. — View Citation

Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9. — View Citation

Sandhu GK, Khinda PK, Gill AS, Kalra HS. Surgical re-entry evaluation of regenerative efficacy of bioactive Gengigel(®) and platelet-rich fibrin in the treatment of grade II furcation: A novel approach. Contemp Clin Dent. 2015 Oct-Dec;6(4):570-3. doi: 10. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the regenerative effect of hyaluronic acid	measurement of the bone gain after the treatment with hyaluronic acid in millimeters	6 months