The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis

September 11, 2021 updated by: Associate Professor Momen Atieh, Mohammed Bin Rashid University of Medicine and Health Sciences

The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis: a Randomized Controlled Trial

Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.

Several studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. The use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues.

The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).

Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
22

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Arab Emirates
      • Dubai, United Arab Emirates, 505097
        • Recruiting
        • Dubai Dental Hospital
        • Contact:
          • Momen A Atieh, BDS, MSc, DClinDent, PhD

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 or over.
  • Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.
  • Good compliance and commitment to attend follow-up review appointments.
  • Willing to provide informed consent.

Exclusion Criteria:

  • Received periodontal treatment in the last 12 months.
  • Received systemic antibiotic in the last 6 months.
  • Pregnancy or lactating participants

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: SINGLE

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: Diode laser (device) with scaling and root planing
Diode laser (device) with conventional scaling and root planing
Procedure: Diode laser (device) with scaling and root planing
Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
ACTIVE_COMPARATOR: Conventional scaling and root planing
Procedure: Conventional scaling and root planing
Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.

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
Full mouth plaque score (FMPS).
Time Frame: Change from baseline FMPS at six months
The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.
Change from baseline FMPS at six months
Full mouth bleeding score (FMBS).
Time Frame: Change from baseline FMBS at six months
The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.
Change from baseline FMBS at six months
Probing pocket depth (PPD).
Time Frame: Change from baseline PPDs at six months
PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
Change from baseline PPDs at six months
Clinical attachment level (CAL).
Time Frame: Change from baseline CALs at six months
CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.
Change from baseline CALs at six months
Number of sites PPDs ≥ 6 mm.
Time Frame: Change from baseline number of sites with PPDs ≥ 6 mm at six months
Number of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
Change from baseline number of sites with PPDs ≥ 6 mm at six months
Percentages of sites PPDs ≥ 6 mm.
Time Frame: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Percentages of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
Change from baseline percentages of sites with PPDs ≥ 6 mm at six 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
Operating time
Time Frame: Outcome measures will be recorded at baseline
Time required to complete the procedure
Outcome measures will be recorded at baseline
Postoperative pain
Time Frame: Change from baseline pain at seven days
Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Change from baseline pain at seven days
Postoperative swelling
Time Frame: Change from baseline swelling at seven days
Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Change from baseline swelling at seven days
Postoperative bleeding
Time Frame: Change from baseline bleeding at seven days
Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Change from baseline bleeding at seven days
Postoperative bruising
Time Frame: Change from baseline bruising at seven days
Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Change from baseline bruising at seven days
Postoperative root sensitivity
Time Frame: Change from baseline root sensitivity at seven days
Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Change from baseline root sensitivity at seven days
Quality of life measures
Time Frame: Change from baseline GOHAI score at six months days

Patient's quality of life will be evaluated using general oral health assessment index (GOHAI). The GOHAI has 12 negatively and positively worded items evaluating three dimensions of oral health related quality of life (physical function, pain or discomfort and psychosocial function).

The score ranged from 0 to 60. The scores are maintained for the three items "able to swallow comfortably", able to eat without discomfort", "pleased with look of teeth", and reversed for the remaining nine items, so that a higher score was associated with a more positive oral health.
Change from baseline GOHAI score at six months days

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.
Mohammed Bin Rashid University of Medicine and Health Sciences

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.
July 28, 2020

Primary Completion (ANTICIPATED)

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.
October 28, 2022

Study Completion (ANTICIPATED)

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.
October 28, 2023

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).
July 3, 2020

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.
July 15, 2020

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.
July 20, 2020

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.
September 14, 2021

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.
September 11, 2021

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.
September 1, 2021

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.
  • MBRU/IRB/2020/006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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