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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04851548
Other study ID # FPFGRP/2021/566
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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 allClick 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
See also
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Not yet recruiting NCT05721313 - Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study N/A
Not yet recruiting NCT05481580 - Restorations and Furcation Involvement on Molars
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Withdrawn NCT03917030 - Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects N/A
Terminated NCT04059458 - Mandibular Furcation III Regeneration (FURC-III-REGEN) Phase 4
Terminated NCT04059445 - Mandibular Furcation II Regeneration Phase 4
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Completed NCT02369250 - Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects Phase 4
Not yet recruiting NCT06116487 - MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars
Completed NCT03578744 - Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects N/A
Recruiting NCT03180658 - Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans N/A
Active, not recruiting NCT05259982 - Vital Root-resective Therapy in Furcation-involved Maxillary Molars N/A
Active, not recruiting NCT02132806 - Piezosurgery in the Treatment of Class II Furcation Involvement N/A
Completed NCT02102360 - Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial. Phase 4
Not yet recruiting NCT06270303 - Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects N/A
Completed NCT03354182 - Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane N/A
Completed NCT04842188 - Furcation Treatment With L-PRF and aPDT N/A