Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets (7-10mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation
NCT Number: NCT06490679
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Pocket|Periodontitis|Gingival Diseases|Gingival Bleeding
Interventions: PROCEDURE: Hand and ultrasonic scalers and curettes|DEVICE: Electro Medical Systems AIRFLOW® Prophylaxis Master Device
Sponsor: Cairo University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2026-01-01
Locations: Faculty of Dentistry, Cairo University, Cairo, Egypt

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.

Primary Outcome Measures: Change in probing pocket depth, The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket., 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.
Secondary Outcome Measures: Bleeding On Probing, The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin., 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.|Clinical Attachment Level, The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect., 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.|Plaque index, The PI will be evaluated by using modified O'Leary index teeth are stained with a disclosing solution, presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined., 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, 0 =absence of calculus

1. =supragingival calculus extending only slightly below the free gingival margin (not more than 1 mm.)
2. = moderate amount of supra and subgingival calculus or subgingival calculus alone
3. = an abundance of supra and subgingival calculus, 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 by using Visual Analogue Score (VAS Score), Minimum 0 = No pain, Maximum 10 = Worst Pain possible, Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention|Patient satisfaction, Patient satisfaction will be measured using a survey., Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention|Cost effectiveness, Ratio of cost of treatment and time of procedure against the gained clinical benefit, At Baseline and 6 months post-op|Treatment time, Time from picking-up the handpiece from the instrument holder to put the handpiece back., Up to 6 months|Number of healed pockets, Pocket depth of \<3.5 mm clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket., 6 months post-op