Adjunctive Use of Salvadora Persica in Chronic Periodontitis

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Salvadora Persica Root; Procedure: Scaling and root planing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zohaib Akram, MSc; Phone Number: 00923343644615; Email: drzohaibakram@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SRP plus salvadora persica root; Subjects receiving salvadora gel in addition to scaling and root planing	Drug: Salvadora Persica Root; Salvadora Persica Gel; Other Names: SP gel; Procedure: Scaling and root planing; Thorough scaling and root planing (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.; Other Names: SRP
Placebo Comparator: SRP only; Subjects receiving scaling and root planing only	Procedure: Scaling and root planing; Thorough scaling and root planing (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.; Other Names: SRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment level	Clinical attachment level (CAL) is the distance from the cemento-enamel junction to the base of the sulcus. It will be measured by a calibrated examiner who will use a UNC 15 probe at 6 points around each tooth. The measurements will be expressed as the nearest millimeters and will be entered into the advanced periodontal chart.	3 months
periodontal pocket depth	Probing depth (PD) is defined as the distance from the gingival margin to the base of the pocket/sulcus.It will be measured by a calibrated examiner, using a UNC 15 probe and expressed in millimetres. The value will be entered into the periodontal chart provided with the questionnaire.	3 months
bleeding on probing	presence or absence of bleeding on probing within 10 seconds around 6 points along each tooth. Presence of bleeding will be marked as 1, while absence will be marked as 0.	3 months
plaque index	presence of absence of plaque along 6 points around each tooth will be examined and entered in the periodontal chart. SItes showing plaque will be marked as 1, while those not showing plaque will be marked as 0.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intrabony defects	Bony defects will be measured on the radiograph by measuring the distance from the cemento-enamel junction to the crest of the bone.	3 months
Porphyramonas gingivalis level	assessment of porphyromona ginivalis levels will be done utilising the Real-time Polymerase Chain Reaction (PCR) at baseline and 3 months.	3 months

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: Ziauddin University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: ZCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No