Clinical trial NCT04477070: The Effects of Subgingival Air-polishing, as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Parameters and Patient Satisfaction in Patients With Periodontitis
Official title: The Effects of Subgingival Air-polishing, as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Parameters and Patient Satisfaction in Patients With 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: no
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 air-polishing devices in combination with ultrasonic debridement in the treatment of gum disease, their use may reduce postoperative pain and discomfort while providing improvement in gum status.

The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined air-polishing 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 air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland). 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.
* Absence of systemic disease that will may affect the treatment outcome.
* Willing to provide informed consent.

Exclusion Criteria:

* Received periodontal treatment in the last 12 months.
* Received systemic anti-inflammatory or antibiotic in the last 6 months or during the study period.
* Use of medication known to affect the gingival growth.
* Chronic bronchitis.
* Asthma.
* Participants that require prophylactic antibiotic.
* Pregnant or breastfeeding 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 depths (PPDs)
timeFrame: Change from baseline PPDs at six months
measure: Clinical attachment levels (CALs)
timeFrame: Change from baseline CALs at six months
measure: Number of sites with PPDs ≥ 6 mm
timeFrame: Change from baseline number of sites with PPDs ≥ 6 mm at six months
measure: Percentages of sites with PPDs ≥ 6 mm
timeFrame: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Secondary outcomes:
measure: Operating time
timeFrame: 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: