Evaluation Of Nonsurgical Treatment Of Shallow Periodontal Pockets (4-6mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in probing pocket depth
Study Overview
Brief Summary
Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.
Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.
The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.
Detailed Description
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University
- Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
- Identifying and recruiting potential subjects will be achieved through patient database.
Preoperative evaluation:
- Clinical examination
Each patient will be examined to confirm that he/she met the eligibility criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Systemically healthy patients.
- •Patients with an age range between 16 to 80 years.
- •Patients have a minimum of 20 teeth.
- •Periodontitis patients with at least one residual pocket with a probing depth ranging from 4 to 6 mm.
- •Cooperative patients able and willing to come for follow up appointments.
Exclusion Criteria
- •Pregnant and lactation females.
- •Patients reporting systemic conditions (eg: diabetes).
- •Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.
- •Patients with severe inflammation and/or osteonecrosis.
Arms & Interventions
Hand and ultrasonic scalers and curettes
Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation.
Intervention: Hand and ultrasonic scalers and curettes (Other)
Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder
An erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device.
Intervention: Electro Medical Systems AIRFLOW® Prophylaxis Master Device (Device)
Outcomes
Primary Outcomes
Change in probing pocket depth
Time Frame: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.
Secondary Outcomes
- Cost effectiveness(At Baseline and 6 months post-op)
- Clinical Attachment Level(CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Treatment time(Up to 6 months)
- Number of healed pockets(6 months post-op)
- Plaque index(PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Calculus index(CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Patient pain/discomfort(Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention)
- Bleeding On Probing(BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Patient satisfaction(Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention)
Investigators
Asim Tariqu Al Ammour
Principal Investigator Asim Al Ammour
Cairo University