| CTRI Number |
CTRI/2023/06/053770 [Registered on: 12/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of air polishing with two different powders as an adjunct to scaling and root planing |
|
Scientific Title of Study
|
Effect of sub gingival air polishing with glycine and erythritol powder as an adjunct to scaling and root planing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMHITHA KOTHAPALLI |
| Designation |
PG student |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO. 8, SECOND FLOOR,
SIBAR DENTAL COLLEGE,
TAKKELLAPADU,
GUNTUR
VIJAYAWADA
Krishna
ANDHRA PRADESH
522509
India |
| Phone |
|
| Fax |
|
| Email |
samhithakothapalli98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K KISHORE KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL SCIENCES, TAKKELLAPADU, GUNTUR
GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SAMHITHA KOTHAPALLI |
| Designation |
PROFESSOR |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 8,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL SCIENCES, TAKKELLAPADU, GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09010237776 |
| Fax |
|
| Email |
samhithakothapalli98@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIBAR INSTITUTE OF DENTAL SCIENCES, TAKKELLAPADU, GUNTUR, ANDHRA PRADESH |
|
|
Primary Sponsor
|
| Name |
SAMHITHA KOTHAPALLI |
| Address |
ROOM NO. 8 ,
SECOND FLOOR,
SIBAR INSTITUTE OF DENTAL SCIENCES, TAKKELLAPADU, GUNTUR |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Samhitha |
Sibar Institute of Dental Sciences |
room no 8
second floor
sibar institute of dental sciences takkellapadu guntur
Guntur
ANDHRA PRADESH |
9010237776
samhithakothapalli98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- SIBAR |
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 |
erythritol powder |
airpolishing is done as an sdjunct to scaling and root planing with glycine powder in one group and erythritol powder in other group
AT BASELINE ONCE AND PARAMETERS WERE CHECKED AT BASELINE AND 8 WEEKS |
| Intervention |
GLYCINE POWDER |
AIRPOLISHING IS DONE AS AN ADJUNCT TO SCALING AND ROOT PLANING WITH GLYCINE POWDER IN ONE GROUP AND ERYTHRITOL POWDER IN OTHER GROUP
at baseline once and parameters were checked at baseline and 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are systemically healthy.
2. Probing pocket depth of ≥5mm and clinical attachment level of ≥5mm.
3. Patients who gave informed consent for the study |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactating females.
2. Radiographic presence of vertical boneloss.
3. Patients who has history of drug allergy.
4. Any form of tobacco consumption.
5. History of previous periodontal surgery since 1 year.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate periodontal parameters at baseline and 8 weeks after SRP with glycine air polishing.
2. To evaluate periodontal parameters and at baseline and 8 weeks after SRP with erythritol air polishing
3. To compare between periodontal parameters between the groups.
|
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate periodontal parameters and at baseline and 8 weeks after SRP with erythritol air polishing
|
BASELINE AND 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 40 patients diagnosed with generalized chronic periodontitis will be selected into the study. The patients were randomly divided into 2 groups according to inclusion and exclusion criteria. Group I: Air polishing with glycine powder (n=20) Group II: Air polishing with erythritol powder (n=20)
At initial visit, clinical examination will be performed on each patient and all the clinical parameters will be recorded . All the patients will receive Phase 1 therapy followed by non surgical periodontal therapy. Patients in group I will receive airpolishing with glycine powder where as group II patients will receive airpolishing with erythritol powder. Brushing technique and oral hygiene instructions will be explained to all the patients. Patients will be recalled after 8 weeks, All the clinical parameters will be recorded at baseline and 3 months postoperatively.
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