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

NCT04477551 | Unknown DMC

• 1 other identifier: MBRU/IRB/2020/006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Operating time

  Outcome measures will be recorded at baseline

• Postoperative pain

  Change from baseline pain at seven days

• Postoperative swelling

  Change from baseline swelling at seven days

• Postoperative bleeding

  Change from baseline bleeding at seven days

• Postoperative bruising

  Change from baseline bruising at seven days

Study Arms (2)

Diode laser (device) with scaling and root planing

EXPERIMENTAL

Diode laser (device) with conventional scaling and root planing

Procedure: Diode laser (device) with scaling and root planing

Conventional scaling and root planing

ACTIVE COMPARATOR

Conventional scaling and root planing

Procedure: Conventional scaling and root planing

Interventions

Diode laser (device) with scaling and root planing PROCEDURE

Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.

Diode laser (device) with scaling and root planing

Conventional scaling and root planing PROCEDURE

Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.

Conventional scaling and root planing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Dubai Dental Hospital

Dubai, 505097, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Lasers, Semiconductor; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

Momen A Atieh, BDS, MSc, DClinDent, PhD

CONTACT

+97143838905; momen.atieh@mbru.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor (Periodontology)

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 20, 2020
• Study Start: July 28, 2020
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

AE (1)