Clinical trial NCT04477551: The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Full mouth plaque score (FMPS).
timeFrame: Change from baseline FMPS at six months
measure: Full mouth bleeding score (FMBS).
timeFrame: Change from baseline FMBS at six months
measure: Probing pocket depth (PPD).
timeFrame: Change from baseline PPDs at six months
measure: Clinical attachment level (CAL).
timeFrame: Change from baseline CALs at six months
measure: Number of sites PPDs ≥ 6 mm.
timeFrame: Change from baseline number of sites with PPDs ≥ 6 mm at six months
measure: Percentages of sites PPDs ≥ 6 mm.
timeFrame: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Secondary outcomes:
measure: Operating time
timeFrame: Outcome measures will be recorded at baseline
measure: Postoperative pain
timeFrame: Change from baseline pain at seven days
measure: Postoperative swelling
timeFrame: Change from baseline swelling at seven days
measure: Postoperative bleeding
timeFrame: Change from baseline bleeding at seven days
measure: Postoperative bruising
timeFrame: Change from baseline bruising at seven days
measure: Postoperative root sensitivity
timeFrame: Change from baseline root sensitivity at seven days
measure: Quality of life measures
timeFrame: Change from baseline GOHAI score at six months days
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Dubai Dental Hospital
Study officials:
References: