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

Phase 4

Completed

• Conditions: Periodontitis Chronic Generalized Severe
• Interventions: Procedure: red injectable platelet rich fibrin (i-prf); Drug: Hyaluronic acid

• Registration Number: NCT05768243
• Lead Sponsor: Beirut Arab University

Brief Summary

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.

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 Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-07-24
• Study Completion: 2022-09-17
• Status Verified: 2023-02
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated with red i-PRF + SRP	red injectable platelet rich fibrin (i-prf)	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.
Treated with hyaluronic acid + SRP	Hyaluronic acid	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).

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	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
Probing Depth	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.

Secondary Outcome Measures

Name	Time	Method
Gingival index	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
Bleeding on Probing	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).
Plaque index	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)

Trial Locations

Locations (1)

Beirut Arab University; 🇱🇧 Beirut, Lebanon