Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490679
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets 7-10mm Using AIRFLOW Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets 7-10mm Using AIRFLOW Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 paindiscomfort 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 heshe met the eligibility criteria
Age gender and smoking status will be collected at baseline along with a complete periodontal charting including 6-point pocket probing depth PPD clinical attachment level CAL plaque index PI according to a modified OLeary index OLeary et al 1972 measured on 6 surfaces per tooth distobuccal buccal mesiobuccal distolingual lingual and mesiolingual Calculus index according to Ramfjord SP 1967
Periapical x-rays will be taken to confirm the diagnosis of periodontitis
Clinical photographs Clinical photographs will be taken at baseline immediately after treatment and 6 months after treatment
Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months
Surgical procedure
Test sites
1 Disclosure of biofilm with erythrosine
2 Removal of supragingival and subgingival up to 4 mm biofilm and stains with the use of AIRFLOW Master Piezon with AIRFLOW PLUS powder EMS- Dental Nyon Switzerland
3 Supra- and sub- gingival debridement by using the AIRFLOW Master Piezon device with Piezon NO PAIN EMS-Dental technology
Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only Pockets 4 mm will be subgingivally debrided using the piezo device according to manufacturers instructions and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits
- Postoperative At the end of the session the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices
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 heshe met the eligibility criteria
Age gender and smoking status will be collected at baseline along with a complete periodontal charting including 6-point pocket probing depth PPD clinical attachment level CAL plaque index PI according to a modified OLeary index OLeary et al 1972 measured on 6 surfaces per tooth distobuccal buccal mesiobuccal distolingual lingual and mesiolingual Calculus index according to Ramfjord SP 1967
Periapical x-rays will be taken to confirm the diagnosis of periodontitis
Clinical photographs Clinical photographs will be taken at baseline immediately after treatment and 6 months after treatment
Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months
Surgical procedure
Test sites
1 Disclosure of biofilm with erythrosine
2 Removal of supragingival and subgingival up to 4 mm biofilm and stains with the use of AIRFLOW Master Piezon with AIRFLOW PLUS powder EMS- Dental Nyon Switzerland
3 Supra- and sub- gingival debridement by using the AIRFLOW Master Piezon device with Piezon NO PAIN EMS-Dental technology
Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only Pockets 4 mm will be subgingivally debrided using the piezo device according to manufacturers instructions and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits
- Postoperative At the end of the session the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None