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

Primary Purpose

Furcation Defects

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyaluronic acid
Sponsored by
Riyadh Elm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects focused on measuring Hyaluronic Acid, Furcation involvement

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A (control)

    Group B (test)

    Arm Description

    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|)

    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|).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2021
    Last Updated
    September 15, 2021
    Sponsor
    Riyadh Elm University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04851548
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 23, 2021 (Anticipated)
    Primary Completion Date
    September 20, 2022 (Anticipated)
    Study Completion Date
    September 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Riyadh Elm University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Furcation Defects
    Keywords
    Hyaluronic Acid, Furcation involvement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (control)
    Arm Type
    Active Comparator
    Arm Description
    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|)
    Arm Title
    Group B (test)
    Arm Type
    Active Comparator
    Arm Description
    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|).
    Intervention Type
    Procedure
    Intervention Name(s)
    hyaluronic acid
    Intervention Description
    after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane
    Primary Outcome Measure Information:
    Title
    evaluate the regenerative effect of hyaluronic acid
    Description
    measurement of the bone gain after the treatment with hyaluronic acid in millimeters
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ghady m alqhtani, BDS
    Phone
    00966541719298
    Email
    ghadi.a.alqahtani2019@student.riyadh.edu.sa
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed t gamal, clinical MD
    Phone
    00966564213932
    Email
    ahmed.tawfig@riyadh.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ahmed t gamal, clinical MD
    Organizational Affiliation
    Riyadh Elm University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    26097373
    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.
    Results Reference
    background
    PubMed Identifier
    25284557
    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.
    Results Reference
    background
    PubMed Identifier
    1058834
    Citation
    Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
    Results Reference
    result
    Citation
    Gaurav Bakutra., et al. "Prevalence, Extension and Severity Associated Risk Factors Associated with Furcation Involvement in an Adult Population. An Epidemiological Study
    Results Reference
    result
    PubMed Identifier
    5259016
    Citation
    Bjorn H, Halling A, Thyberg H. Radiographic assessment of marginal bone loss. Odontol Revy. 1969;20(2):165-79. No abstract available.
    Results Reference
    result
    Citation
    Carranza, F. A. & Newman, M. G., 2018. Clinical Periodontology. USA: WB Saunders & Co.
    Results Reference
    result
    Citation
    Glickman, I. (1972). Clinical Periodontology: Prevention, Diagnosis, and Treatment of Periodontal Disease in the Practice of General Dentistry (4th ed.). Saunder.
    Results Reference
    result
    PubMed Identifier
    30041399
    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.
    Results Reference
    result
    PubMed Identifier
    26681869
    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.
    Results Reference
    result
    PubMed Identifier
    21829786
    Citation
    Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9.
    Results Reference
    result
    Citation
    https://doi.org/10.1902/jop.1959.30.1.7
    Results Reference
    result

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

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