Chronic Periodontitis Clinical Trial
Official title:
Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by comparing the basic parameters of periodontitis, radiographs and bacterial levels with a controlled group (SRP only).
Sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected
by convenience sampling. The participants will be randomly divided into 2 groups:
1. Test group: SRP + SP gel
2. Control group: SRP only
Each participant will undergo treatment in the following steps:
1. QUESTIONNAIRE:
All participants will complete a structured baseline questionnaire provided by one
trained interviewer that will include the data regarding; (a) age; (2) gender; (3)
education status; (4) occupation; (5) medical status
2. INFORMED CONSENT:
All eligible subjects will be thoroughly informed of the nature, potential risks and
benefits of their participation in the study.
3. ASSESSMENT OF PARAMETERS:
1. CLINICAL PERIODONTAL PARAMETERS Full-mouth plaque index (PI), bleeding on probing
(BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded on
baseline, 6th week and 12th week for all the patients that pass the inclusion
criteria.
2. RADIOGRAPHIC ANALYSIS The depth of bony defects (BD) will be evaluated at baseline,
6 and 12 weeks using image analysis software (Scion Image Analyzer, Scion,
Frederick, MD, USA).
3. ANALYSIS OF PLAQUE MICROORGANISM Subgingival plaque will be collected at baseline
and 12 weeks from the deepest PD (>4mm) of each patient.
4. SCALING AND ROOT PLANING After baseline recordings, thorough SRP will be performed by a
single clinician. The SRP procedure will be carried out in two sittings, comprising of
ultrasonic scaling in the first, and manual instrumentation and root debridement in the
second.
5. APPLICATION OF SP GEL In the test group, areas with PPD greater than 4 mm will be marked
on the periodontal chart. In these areas SP gel will be placed following root planing
procedure.
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