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Status unknownNCT04851548Updated Sep 17, 2021

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

An interventional study of hyaluronic acid in Furcation Defects, sponsored by Riyadh Elm University. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Riyadh Elm University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

Read the 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.
02

Conditions studied

  • Furcation Defects

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Keywords

  • Hyaluronic Acid
  • Furcation involvement
03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's planned enrollment of 18 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    Group A (control)

    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

  • Active comparator
    Group B (test)

    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

  • Procedurehyaluronic acid

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

06

What researchers measure

Primary outcomes

  1. evaluate the regenerative effect of hyaluronic acid

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04851548
Lead sponsor
Riyadh Elm University
Responsible party
Ghady Adnan Alqahtani (periodontic resident, Riyadh Elm University) — Principal investigator
First posted
Apr 20, 2021
Start date
Sep 23, 2021 (estimated)
Primary completion
Sep 20, 2022 (estimated)
Completion
Sep 20, 2022 (estimated)
Last update
Sep 17, 2021

Study contacts

ghady m alqhtani, BDS
Contact
ghadi.a.alqahtani2019@student.riyadh.edu.sa
00966541719298
ahmed t gamal, clinical MD
Contact
ahmed.tawfig@riyadh.edu.sa
00966564213932
ahmed t gamal, clinical MD
study director · Riyadh Elm University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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