NCT03770819

Brief Summary

The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

December 6, 2018

Last Update Submit

February 25, 2019

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Microbial profile

    Change in levels of P.gingivalis following PDT

    3 months

Secondary Outcomes (4)

  • Change in Plaque index score

    3 months

  • Change in Gingival index score

    3 months

  • Probing pocket depth

    3 months

  • Clinical attachment level

    3 months

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

Application of placebo gel followed by sham Photodynamic therapy

Procedure: Photodynamic therapy

Zinc oxide gel group

ACTIVE COMPARATOR

Application of Zinc oxide gel followed by sham Photodynamic therapy.

Procedure: Photodynamic therapy

PDT group

EXPERIMENTAL

Application of placebo gel followed by Photodynamic therapy.

Procedure: Photodynamic therapy

Zinc oxide and PDT group

EXPERIMENTAL

Application of Zinc oxide gel followed by Photodynamic therapy.

Procedure: Photodynamic therapy

Interventions

Photodynamic therapyPROCEDURE

Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride). For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.

PDT groupPlacebo groupZinc oxide and PDT groupZinc oxide gel group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
  • Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.

You may not qualify if:

  • Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
  • Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
  • Chronic Smokers, Alcoholics, Smokeless tobacco users.
  • Subjects with acute illnesses/acute intraoral lesions.
  • Pregnant women and lactating mothers.
  • Medically compromised subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Study period - 3 months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader, Department of Periodontics

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

March 1, 2019

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02