Clinical trial NCT04851548: Evaluate the Effect of Hyaluronic Acid in the Treatment of Furcation Involvement
Official title: Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Furcation Defects
Keywords: Hyaluronic Acid
Furcation involvement
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: evaluate the regenerative effect of hyaluronic acid
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riyadh Elm University
name: ahmed t gamal, clinical MD
role: STUDY_DIRECTOR
References:
citation: Kalra SH, Monga C, Kalra KH, Kalra SH. A roentgenographic assessment of regenerative efficacy of bioactive Gengigel((R)) 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.
citation: Sahayata VN, Bhavsar NV, Brahmbhatt NA. An evaluation of 0.2% hyaluronic acid gel (Gengigel (R)) in the treatment of gingivitis: a clinical & microbiological study. Oral Health Dent Manag. 2014 Sep;13(3):779-85.
citation: Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
citation: Gaurav Bakutra., et al. "Prevalence, Extension and Severity Associated Risk Factors Associated with Furcation Involvement in an Adult Population. An Epidemiological Study
citation: Bjorn H, Halling A, Thyberg H. Radiographic assessment of marginal bone loss. Odontol Revy. 1969;20(2):165-79. No abstract available.
citation: Carranza, F. A. & Newman, M. G., 2018. Clinical Periodontology. USA: WB Saunders & Co.
citation: Glickman, I. (1972). Clinical Periodontology: Prevention, Diagnosis, and Treatment of Periodontal Disease in the Practice of General Dentistry (4th ed.). Saunder.
citation: Pilloni A, Rojas MA. Furcation Involvement Classification: A Comprehensive Review and a New System Proposal. Dent J (Basel). 2018 Jul 23;6(3):34. doi: 10.3390/dj6030034.
citation: Sandhu GK, Khinda PK, Gill AS, Kalra HS. Surgical re-entry evaluation of regenerative efficacy of bioactive Gengigel((R)) 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: 10.4103/0976-237X.169855.
citation: Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9.
citation: https://doi.org/10.1902/jop.1959.30.1.7