Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT03749369
Status:
UNKNOWN
Last Update Posted:
2019-03-01
First Post:
2018-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Use of Salvadora Persica in Chronic Periodontitis
Sponsor:
King Saud University
Organization:
Study Overview
Official Title:
Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: