| CTRI Number |
CTRI/2025/06/088488 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The beneficial effect of added use of supragingival air polishing treatment with erythritol powder compared to normal SRP alone during phase 1 periodontal treatment |
|
Scientific Title of Study
|
The efficacy of adjunct use of supragingival air polishing therapy with erythritol powder compared to conventional SRP alone during phase 1 periodontal therapy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi D |
| Designation |
MDS Postgraduate |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Room no .5
Department of Periodontology
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
1 Mount Poonamallee Rd
Sri Ramachandra nagar
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9071946580 |
| Fax |
|
| Email |
swathideva62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Moses Ravindran |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Room no.5
Department of Periodontology
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
1 Mount Poonamallee Rd
Sri Ramachandra nagar
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841311211 |
| Fax |
|
| Email |
deepak_perio@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Moses Ravindran |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Room no.5
Department of Periodontology
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
1 Mount Poonamallee Rd
Sri Ramachandra nagar
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841311211 |
| Fax |
|
| Email |
deepak_perio@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| NILSRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
1 Mount Poonamallee Rd
Sri Ramachandra nagar
Porur
Chennai |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no 5
Department of Periodontology
Sri Ramachandra Institute of Higher Education and Research
1 Mount Poonamallee Rd
Sri Ramachandra Nagar
Iyyappanthangal
Chennai
Tamil Nadu |
| Type of Sponsor |
Other [Dental College and research institute] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DEEPAK MOSES RAVINDRAN |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
1 Mount Poonamallee Rd
Sri Ramachandra nagar
Porur
Chennai
Chennai
TAMIL NADU |
9841311211
deepak_perio@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Scaling and Root planning |
| Intervention |
Erythritol powder and SRP |
Erythritol powder in adjunct with Scaling and root planning |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with periodontitis had completed comprehensive periodontal therapy at least three months and were in their maintenance period.
2. Periodontal PD not more than 5 mm.
3. Remaining more than 20 teeth.
4. Without systemic disease.
5. No smoking.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who use tobacco in any form.
2. Subjects who have periodontal disease and are undergoing orthodontic treatment previously underwent maxillofacial surgery.
3. Subjects who have taken antibiotics in the past 6 months.
4. Subjects who Have taken analgesics in past 1week.
5. Pregnant and lactating women.
6. Subjects with a previous history of surgical periodontal therapy
7. Patients unable to maintain sufficient oral hygiene were also excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in bleeding on probing, Clinical attachment loss and Pocket probing Depth. |
Baseline and 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial(Porphyromonas gingivalis) load |
Baseline and 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 12 patients with Grade 2 periodontitis were choosen for this split mouth study, randomly quadrants were selected for test and control groups in this single centred, clinical trial. Each group including 12 quadrants were randomly selected for test and control group. Test group will be treated with scaling and root planning with erythritol powder supragingival air polishing as adjunct.Control group will be treated with Scaling and root planning alone. Every patient who satisfies the requirements for inclusion will be progressively included to the experiment . Using an envelope system and a computer generated table, Each patient will be randomly assigned to receive either the test group (scaling and root planning with erythritol powder supragingival air polishing as adjunct) and Control group(Scaling and root planning alone). Patients in the test group will be treated with conventional SRP with supragingival erythritol air polishing device using Prophyjet air polishing device for 5 seconds each tooth. To assess the changes in the clinical periodontal parameters( Bleeding on probing, plaque index, Probing depth, clinical attachment loss and PISA) and microbial analysis using plaque samples at baseline and 3 weeks follow up period. The non- surgical periodontal therapy for the assigned patients will be performed in the department of periodontology, prior to therapy, all study participants underwent a comprehensive diagnostic evaluation that comprised a radiograph of the afflicted area, intraoral photos, and routine blood parameter checks, bleeding time, clotting time .A comprehensive oral prophylaxis were then carried out . The modified plaque index( Silness and Loe, 1964) , the modified sulcus bleeding index ( Mombelli et al., 1987 ) will be done to quantify oral hygiene at baseline for all the patients prior to oral prophylaxis. Using the UNC-15 probe, the probing pocket depth and clinical attachment loss will be assessed. Clinical parameters( Bleeding on probing, plaque index, Probing depth, clinical attachment loss and PISA) and microbial analysis will be assessed at baseline and 4 weeks following the initial instrumentation. |