NCT03749369

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

November 19, 2018

Last Update Submit

February 28, 2019

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • intrabony defects

    3 months

  • Porphyramonas gingivalis level

    3 months

Study Arms (2)

SRP plus salvadora persica root

ACTIVE COMPARATOR

Subjects receiving salvadora gel in addition to scaling and root planing

Drug: Salvadora Persica RootProcedure: Scaling and root planing

SRP only

PLACEBO COMPARATOR

Subjects receiving scaling and root planing only

Procedure: Scaling and root planing

Interventions

Salvadora Persica RootDRUG

Salvadora Persica Gel

Also known as: SP gel
SRP plus salvadora persica root
Scaling and root planingPROCEDURE

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.

Also known as: SRP
SRP onlySRP plus salvadora persica root

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are \>30 years old
  • Minimum of 20 teeth , excluding third molars
  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Central Study Contacts

Zohaib Akram, MSc

CONTACT

00923343644615drzohaibakram@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

April 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02