Hyaluronic Acid Versus Red Injectable Platelet Rich Fibrin in Treatment of Periodontitis
Condition: Periodontitis Chronic Generalized Severe
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Hyaluronic acid; red injectable platelet rich fibrin (i-prf)
Intervention type(s): Drug; Procedure
Intervention description(s): hyaluronic acid is used as an adjunctive treatment to scaling and root planing; injecting red i-prf into the pocket after scaling and root planing
Other intervention name(s): GENGIGEL®
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment