Furcation DefectsNCT04851548
Evaluate the Effect of Hyaluronic Acid in the Treatment of Furcation Involvement
A study testing hyaluronic acid in people with Furcation Defects, run by Riyadh Elm University.
Trial summary
the effect Hyaluronic Acid in the Treatment of Furcation Involvement Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- hyaluronic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement
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.
- Conditions
- Furcation Defects
- Being tested
- hyaluronic acid
- Keywords
- Hyaluronic Acid, Furcation involvement
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acidProcedure or surgery
after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| 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|) Receives: 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|). Receives: Procedure: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the regenerative effect of hyaluronic acid
measurement of the bone gain after the treatment with hyaluronic acid in millimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start23 Sep 2021 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghady Adnan Alqahtani, Riyadh Elm University
- Investigators
- ahmed t gamal, clinical MD, Study director, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851548
- Sponsor's protocol ID
- FPFGRP/2021/566
- Status last verified
- Sep 2021
- First submitted
- 3 Mar 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 26097373Sahayata 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 25284557Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834Gaurav 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 5259016Carranza, 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 30041399Sandhu 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 26681869Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9.
PubMed 21829786https://doi.org/10.1902/jop.1959.30.1.7
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement
- ClinicalTrials.gov ID
- NCT04851548
- Acronym / sponsor ID
- FPFGRP/2021/566
- Conditions
- Furcation Defects
- Keywords
- Hyaluronic Acid, Furcation involvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 23 Sep 2021 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- test group use membrane and hyaluronic acid ,control group use membrane without hyaluronic acid
| Arm | Type | Receives |
|---|---|---|
| Group A (control) | Active comparator | Procedure: hyaluronic acidpreoperative 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|) |
| Group B (test) | Active comparator | Procedure: hyaluronic acidpreoperative 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|). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Patients that received periodontal regenerative therapy within the past 12 months.
- Patients that are lactating.
- Pregnant patients.
- Smokers.
- Patients with pulp infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acidafter flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane | Procedure or surgery | Group A (control), Group B (test) |
Primary outcome
evaluate the regenerative effect of hyaluronic acid
Time frame: 6 months
measurement of the bone gain after the treatment with hyaluronic acid in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 26097373Kalra 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.
- Background: PubMed 25284557Sahayata 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 publication: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- Results publicationGaurav Bakutra., et al. "Prevalence, Extension and Severity Associated Risk Factors Associated with Furcation Involvement in an Adult Population. An Epidemiological Study
- Results publication: PubMed 5259016Bjorn H, Halling A, Thyberg H. Radiographic assessment of marginal bone loss. Odontol Revy. 1969;20(2):165-79. No abstract available.
- Results publicationCarranza, F. A. & Newman, M. G., 2018. Clinical Periodontology. USA: WB Saunders & Co.
- Results publicationGlickman, I. (1972). Clinical Periodontology: Prevention, Diagnosis, and Treatment of Periodontal Disease in the Practice of General Dentistry (4th ed.). Saunder.
- Results publication: PubMed 30041399Pilloni 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 publication: PubMed 26681869Sandhu 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 publication: PubMed 21829786Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010 Apr;1(2):67-9.
- Results publicationhttps://doi.org/10.1902/jop.1959.30.1.7
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed t gamal, clinical MD study director
Riyadh Elm University
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid in people with Furcation Defects, run by Riyadh Elm University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ghady m alqhtani, BDS (00966541719298, ghadi.a.alqahtani2019@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the regenerative effect of hyaluronic acid (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851548, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.