Adjunctive Use of Salvadora Persica in Chronic Periodontitis

Status Not yet recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03749369
Study type	Interventional
Source	King Saud University
Contact	Zohaib Akram, MSc
Phone	00923343644615
Email	drzohaibakram@gmail.com
Status	Not yet recruiting
Phase	Early Phase 1
Start date	April 1, 2019
Completion date	October 1, 2019

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.