Clinical trial NCT03749369: Adjunctive Use of Salvadora Persica in Chronic Periodontitis
Official title: Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Periodontitis
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: Ziauddin University
First posted: 2018-11-21
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are \>30 years old
2. Minimum of 20 teeth , excluding third molars
3. Systemically healthy patients with moderate (PD of 5 to 6 mm or clinical attachment loss CAL of 4 to 6 mm) or deep pockets (PD ≥7mm or CAL of 6 to 9 mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs (Armitage 1999)

Exclusion Criteria:

1. Presence of systemic conditions that could modify the progression of periodontitis such as diabetes mellitus, metabolic syndrome, cardiovascular disease or immunologic disorders
2. Systemic antimicrobials in the previous 6 months
3. Aggressive periodontitis
4. Pregnancy or lactation
5. Inability to provide informed consent

Primary outcomes:
measure: clinical attachment level
timeFrame: 3 months
measure: periodontal pocket depth
timeFrame: 3 months
measure: bleeding on probing
timeFrame: 3 months
measure: plaque index
timeFrame: 3 months
Secondary outcomes:
measure: intrabony defects
timeFrame: 3 months
measure: Porphyramonas gingivalis level
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: