Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University
Preoperative evaluation:
- Clinical examination
Each patient will be examined to confirm that he/she 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 O'Leary index (O'Leary 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.
Test sites:
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 manufacturer's 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand and ultrasonic scalers and curettes | Experimental | Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation. |
|
| Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder | Active Comparator | An erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro Medical Systems AIRFLOW® Prophylaxis Master Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asim Al Ammour, Bachelor | Contact | +201030593878 | asim.alammour@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hani El-Nahas, Professor | Cairo University | Study Director |
| Omnia Tawfik, Lecturer | Cairo University | Study Chair |
| Asim Al Ammour, Bachelor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hand and ultrasonic scalers and curettes | Other | Combination of ultrasonic and hand instrumentation only. Pockets ≥4 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits. |
|
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
| 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 (0-10) | 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 |
| Cairo University |
| Principal Investigator |
| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| D010518 | Periodontitis |
| D005882 | Gingival Diseases |
| D005884 | Gingival Hemorrhage |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006472 | Oral Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided