Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjunctive Use of Salvadora Persica in Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03749369
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Ziauddin University
Information provided by (Responsible Party):
Zohaib Akram, King Saud University

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).

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Salvadora Persica Root Procedure: Scaling and root planing Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

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 Name: 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 Name: 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 Name: SRP




Primary Outcome Measures :
  1. clinical attachment level [ Time Frame: 3 months ]
    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.

  2. periodontal pocket depth [ Time Frame: 3 months ]
    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. bleeding on probing [ Time Frame: 3 months ]
    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.

  4. plaque index [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. intrabony defects [ Time Frame: 3 months ]
    Bony defects will be measured on the radiograph by measuring the distance from the cemento-enamel junction to the crest of the bone.

  2. Porphyramonas gingivalis level [ Time Frame: 3 months ]
    assessment of porphyromona ginivalis levels will be done utilising the Real-time Polymerase Chain Reaction (PCR) at baseline and 3 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749369


Contacts
Layout table for location contacts
Contact: Zohaib Akram, MSc 00923343644615 drzohaibakram@gmail.com

Sponsors and Collaborators
King Saud University
Ziauddin University

Layout table for additonal information
Responsible Party: Zohaib Akram, Senior Registrar, King Saud University
ClinicalTrials.gov Identifier: NCT03749369     History of Changes
Other Study ID Numbers: ZCD
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases