The Effects of Subgingival Air-polishing, as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Parameters and Patient Satisfaction in Patients With Periodontitis
Primary Purpose
Periodontal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Air-polishing with ultrasonic debridement
Conventional scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
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
Sites / Locations
- Dubai Dental HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Air-polishing with ultrasonic debridement
Conventional scaling and root planing.
Arm Description
Air-polishing with ultrasonic debridement
Conventional scaling and root planing.
Outcomes
Primary Outcome Measures
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.
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.
Probing pocket depths (PPDs)
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.
Clinical attachment levels (CALs)
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 with 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.
Percentages of sites with 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.
Secondary Outcome Measures
Operating time
Time required to complete the treatment
Postoperative pain
Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Postoperative swelling
Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Postoperative bleeding
Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Postoperative bruising
Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
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
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.
Full Information
NCT ID
NCT04477070
First Posted
July 3, 2020
Last Updated
September 11, 2021
Sponsor
Mohammed Bin Rashid University of Medicine and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04477070
Brief 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
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
October 21, 2022 (Anticipated)
Study Completion Date
October 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mohammed Bin Rashid University of Medicine and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air-polishing with ultrasonic debridement
Arm Type
Experimental
Arm Description
Air-polishing with ultrasonic debridement
Arm Title
Conventional scaling and root planing.
Arm Type
Active Comparator
Arm Description
Conventional scaling and root planing.
Intervention Type
Procedure
Intervention Name(s)
Air-polishing with ultrasonic debridement
Intervention Description
Use of air-polishing and ultrasonic device (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) to remove plaque and calculus from the surface of the roots of teeth.
Intervention Type
Procedure
Intervention Name(s)
Conventional scaling and root planing
Intervention Description
Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
Primary Outcome Measure Information:
Title
Full mouth plaque score (FMPS)
Description
The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.
Time Frame
Change from baseline FMPS at six months
Title
Full mouth bleeding score (FMBS)
Description
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.
Time Frame
Change from baseline FMBS at six months
Title
Probing pocket depths (PPDs)
Description
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.
Time Frame
Change from baseline PPDs at six months
Title
Clinical attachment levels (CALs)
Description
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.
Time Frame
Change from baseline CALs at six months
Title
Number of sites with PPDs ≥ 6 mm
Description
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.
Time Frame
Change from baseline number of sites with PPDs ≥ 6 mm at six months
Title
Percentages of sites with PPDs ≥ 6 mm
Description
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.
Time Frame
Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Secondary Outcome Measure Information:
Title
Operating time
Description
Time required to complete the treatment
Time Frame
Baseline
Title
Postoperative pain
Description
Patient-related outcomes (pain) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Time Frame
Change from baseline pain at seven days
Title
Postoperative swelling
Description
Patient-related outcomes (swelling) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Time Frame
Change from baseline swelling at seven days
Title
Postoperative bleeding
Description
Patient-related outcomes (bleeding) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Time Frame
Change from baseline bleeding at seven days
Title
Postoperative bruising
Description
Patient-related outcomes (bruising) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Time Frame
Change from baseline bruising at seven days
Title
Postoperative root sensitivity
Description
Patient-related outcomes (root sensitivity) will be measured using visual analogue scale Minimum score 0 Maximum score 10 Higher score indicates worse outcome
Time Frame
Change from baseline root sensitivity at seven days
Title
Quality of life measures
Description
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.
Time Frame
Change from baseline GOHAI score at six months days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Momen A Atieh, BDS, MSc, DClinDent, PhD
Phone
+97143838905
Email
momen.atieh@mbru.ac.ae
Facility Information:
Facility Name
Dubai Dental Hospital
City
Dubai
ZIP/Postal Code
505097
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Momen A Atieh, BDS, MSc, DClinDent, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Subgingival Air-polishing, as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Parameters and Patient Satisfaction in Patients With Periodontitis
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