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

NCT04851548 | Unknown DMC

• 1 other identifier: FPFGRP/2021/566
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

Conditions

Furcation Defects

Keywords

Hyaluronic Acid; Furcation involvement

Outcome Measures

Primary Outcomes (1)

• evaluate the regenerative effect of hyaluronic acid

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

  6 months

Study Arms (2)

Group A (control)

ACTIVE COMPARATOR

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

Group B (test)

ACTIVE COMPARATOR

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

Interventions

hyaluronic acid PROCEDURE

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

Group A (control); Group B (test)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Selected teeth: Permanent first and second molars in the mandible.
• 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.
• Gender: both males and females.
• Age range: between 18 and 55 years.
• Health status: healthy patients non-systemic diseased except controlled diabetic.
• Compliance: Patients will be willing and able to comply with adequate oral hygiene protocols.

You may not qualify if:

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

Sponsors & Collaborators

• Riyadh Elm University: lead

Related Publications (11)

• 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.

  PMID: 26097373 BACKGROUND

• 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.

  PMID: 25284557 BACKGROUND

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

  PMID: 1058834 RESULT

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

  RESULT

• Bjorn H, Halling A, Thyberg H. Radiographic assessment of marginal bone loss. Odontol Revy. 1969;20(2):165-79. No abstract available.

  PMID: 5259016 RESULT

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

  RESULT

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

  RESULT

• 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.

  PMID: 30041399 RESULT

• 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.

  PMID: 26681869 RESULT

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

  PMID: 21829786 RESULT

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

  RESULT

MeSH Terms

Conditions

Furcation Defects

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• ahmed t gamal, clinical MD

  Riyadh Elm University

  STUDY DIRECTOR

Central Study Contacts

ghady m alqhtani, BDS

CONTACT

00966541719298; ghadi.a.alqahtani2019@student.riyadh.edu.sa

ahmed t gamal, clinical MD

CONTACT

00966564213932; ahmed.tawfig@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: periodontic resident

Model Details: test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: April 20, 2021
• Study Start: September 23, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share