Hyaluronic Acid Versus Red Injectable Platelet Rich Fibrin in Treatment of Periodontitis

March 13, 2023 updated by: Beirut Arab University

Efficiency of Hyaluronic Acid Versus Red Injectable Platelet-Rich Fibrin (i-PRF) in Treatment of Stage III Periodontitis (Randomized Controlled Clinical Trial)

the aim of this clinical trial is to compare the efficacy of hyaluronic acid (HA) used as an adjunctive to scaling and root planing (SRP) and red injectable platelet rich-fibrin (i-PRF) in the non-surgical treatment of stage III periodontitis. The main question it aims to answer is: is there a difference between HA and red i-prf when used as an adjunct to SRP in terms of efficacy?

Participants who are eligible will be assigned to one of the treatment groups:

  • Group 1= receives HA+ SRP
  • Group 2= receives red i-prf + SRP
  • Group 3= receives only SRP

Researchers will compare Groups 1,2 and 3 to see if there's a difference in the periodontal parameters measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complete medical and dental histories as well as informed consent will be collected from eligible participants, and periodontal charting will be done for them.

The selected patients will be allocated into three groups (each containing 25) with the help of a computerized randomizer (Randomizer.org):

  • Group one (G1): 25 patients will be treated with hyaluronic acid gel as an adjunct to scaling and root planing by applying one ml of 0.8% HA to the base of the pocket (subgingivally) and 0.2 ml of 0.2% HA topically (applied by the patient).
  • Group two (G2): 25 patients will be treated with red i-PRF as an adjunct to scaling and root planing.
  • Group three (G3): 25 patients will be treated with scaling and root planing only.

The clinical examiner will not be informed of the treatment groups' distribution.

Before the baseline examination, a full mouth supragingival scaling and root planing will be performed under local anesthesia in one or two sessions (over a 24-hour period). Patients will be informed on self-performed plaque control measures, including using the modified Bass brushing technique using a soft toothbrush and regular toothpaste twice a day and interdental cleaning using interdental brushes once a day. Patients will receive the same toothbrushes, toothpaste, and interdental brushes.

The clinical parameters will be recorded at the baseline (1st visit) before the treatment and will be repeated in the fourth week (2nd visit), eighth week (3rd visit), and twelfth week (fourth visit). During this period, reinforcement of plaque control will be given to maintain good oral hygiene.

Data from previous studies will be used to calculate the sample size (Zijnge et al., 2010) regarding the PD change measurement. It is found that the difference in PD (δ) is around 0.3mm, whereas the standard deviation in groups (σ) is around 0.2mm. Our aim is to achieve a statistical power of > 90% as well as a 0.05 significance level. Thus, 18 participants per group will be needed. However, as some dropouts may be expected, a minimum of 25 patients per group will be recruited.

Statistical analysis will be done using SAS 9.4 Software (SAS Institute Inc., Cary, NC, USA). Means and standard deviations (SD) will be calculated for all continuous variables (periodontal parameters: CAL, PD, BOP, GI, PI) at the baseline, fourth week, eighth week, and twelfth week. Repeated linear mixed-effects models (PROC MIXED in SAS) will be used to examine the changes in all periodontal parameters over the four-time points within each group and between groups. An unstructured covariance matrix will be used, residual plots will be visually reviewed to check model fit, and extreme outliers will be eliminated using the restricted likelihood distance. A Tukey-Kramer correction will be applied to all pairwise comparisons. One-way ANOVA is to be used to examine group differences in PD reduction and CAL. A p-value of 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Beirut Arab University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical periodontal loss and radiographic bone loss of stage III/grades A and B with no history of systemic disease.
  • at least four periodontal sites with a pocket depth of six mm or greater
  • radiographic evidence of bone loss extending to the middle third of the root
  • clinical attachment loss of five mm or more

Exclusion Criteria:

  • uncontrolled systemic conditions (uncontrolled diabetes or uncontrolled hypertension)
  • bleeding disorders, or on anticoagulant therapy
  • alcohol users
  • pregnant or lactating females
  • heavy smokers (more than ten cigarettes per day)
  • chemo or radio therapy
  • antibiotic/anti-inflammatory drugs over the last three months before treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated with hyaluronic acid + SRP
After scaling and root planing, hyaluronic acid (GENGIGEL®) will be applied in the following forms (one ml of 0.8% HA was injected subgingivally once every four weeks), topically (0.2 ml of 0.8% HA applied by the patient twice daily for the following 14 days after the subgingival application).
Drug: Hyaluronic acid
hyaluronic acid is used as an adjunctive treatment to scaling and root planing
Other Names:
  • GENGIGEL®
Experimental: Treated with red i-PRF + SRP
The red i-PRF will be injected into the pocket at the point of interdental space after SRP. Moreover, to control bleeding due to the needle tip after the procedure, a saline-soaked sponge will be placed between the lip and the gingiva and removed after 15 minutes. A total of four sessions of i-PRF will be administered to patients at a ten-day interval.
Procedure: red injectable platelet rich fibrin (i-prf)
injecting red i-prf into the pocket after scaling and root planing
No Intervention: Scaling and root planing only
no adjunctive treatment will be done to scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: 4 weeks
used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket
4 weeks
Probing Depth
Time Frame: 4 weeks
used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing
Time Frame: 4 weeks
It is an indicator of periodontal tissue inflammatory response. The probe is carefully introduced to the bottom of the pocket and gently moved laterally along the pocket wall. Depending on the severity of inflammation, bleeding can vary from a tenuous red line along the gingival sulcus to profuse bleeding (immediately after probing or few seconds after).
4 weeks
Plaque index
Time Frame: 4 weeks
used to evaluate the level and rate of plaque formation on tooth surfaces. It measures the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The amount of plaque is determined with disclosing solution and a range of scores of 0-5 is assigned with 0 denoting no plaque and 5 denoting heavy plaque (covering 2/3 of the tooth crown)
4 weeks
Gingival index
Time Frame: 4 weeks
used to assess the severity of gingival inflammation. Scores ranges from 0-3 with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. This measurement is based on the presence or absence of bleeding on gentle probing
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beirut Arab University

Investigators

  • Study Chair: Nayer Aboelsaad, PhD, Professor and Chairman of Periodontology department - BeirutArabU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 24, 2022

Study Completion (Actual)

September 17, 2022

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-H-0075-D-R-0293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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