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

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: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Diode laser (device) with scaling and root planing; Procedure: Conventional scaling and root planing

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momen A Atieh, BDS, MSc, DClinDent, PhD; Phone Number: +97143838905; Email: momen.atieh@mbru.ac.ae

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Full mouth plaque score (FMPS).	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).	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).	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).	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.	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.	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

Outcome Measure	Measure Description	Time Frame
Operating time	Time required to complete the procedure	Outcome measures will be recorded at baseline
Postoperative pain	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	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	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	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	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	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

• Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2020
• Primary Completion (ANTICIPATED): October 28, 2022
• Study Completion (ANTICIPATED): October 28, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID 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