Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

October 6, 2017 updated by: Zohaib Akram, King Saud University

Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial

This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1 month and 3 months' follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

42 years to 52 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Self-reported habitual cigarette-smokers.
  • Self-reported never-smokers.
  • Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

Exclusion Criteria:

  • Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
  • Habitual smokeless tobacco product and alcohol users.
  • Third molars and fractured teeth with embedded root remnants and edentulous individuals.
  • Patients with misaligned teeth.
  • Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Adjunctive photodynamic therapy
This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)
Device: Photodynamic therapy
In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.
Procedure: Scaling and root planing (SRP)
In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.
ACTIVE_COMPARATOR: Dental scaling
This arm will be given scaling and root planing (SRP) only
Device: Photodynamic therapy
In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.
Procedure: Scaling and root planing (SRP)
In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 3 months
Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)
3 months
Clinical attachment level gain
Time Frame: 3 months
Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: 3 months

Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque

1 - Visible plaque
3 months
Bleeding on probing
Time Frame: 3 months

Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding

1 - Visible bleeding
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FR-17-87

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary outcome measures will be made available

IPD Sharing Time Frame

Data is available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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