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Clinical Trials/NCT04477551
NCT04477551
Unknown
Not Applicable

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

Mohammed Bin Rashid University of Medicine and Health Sciences1 site in 1 country22 target enrollmentJuly 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Diseases
Sponsor
Mohammed Bin Rashid University of Medicine and Health Sciences
Enrollment
22
Locations
1
Primary Endpoint
Full mouth plaque score (FMPS).
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 28, 2020
End Date
October 28, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Associate Professor Momen Atieh

Chair and Associate Professor (Periodontology)

Mohammed Bin Rashid University of Medicine and Health Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Postoperative bruising(Change from baseline bruising at seven days)
  • Postoperative pain(Change from baseline pain at seven days)
  • Postoperative bleeding(Change from baseline bleeding at seven days)
  • Postoperative root sensitivity(Change from baseline root sensitivity at seven days)
  • Quality of life measures(Change from baseline GOHAI score at six months days)
  • Operating time(Outcome measures will be recorded at baseline)
  • Postoperative swelling(Change from baseline swelling at seven days)

Study Sites (1)

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