| CTRI Number |
CTRI/2025/07/091678 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Heal your gums without surgery The perio protect method |
|
Scientific Title of Study
|
Examining Periodontal Wellness: Effectiveness of Non-Surgical Intervention
Utilizing the Perio Protect Method |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sravani Korukonda |
| Designation |
Student |
| Affiliation |
Lenora institute of dental sciences |
| Address |
Department of Periodontics,NH 16,Near HP Petrol Pump, Rajanagaram,Rajamahendravaram.
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
8309397729 |
| Fax |
|
| Email |
korukondasravani08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santhi |
| Designation |
Reader |
| Affiliation |
Lenora Institute Of Dental Sciences |
| Address |
Department of Periodontics,NH 16,Near HP Petrol Pump, Rajanagaram,Rajamahendravaram.
Department of Periodontics NH-16,Near HP Petrol Pump,Rajanagaram,Rajamahendaram
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9052120645 |
| Fax |
|
| Email |
dhaliya2011@gmail.cam |
|
Details of Contact Person
Public Query
|
| Name |
Santhi |
| Designation |
Reader |
| Affiliation |
Lenora Institute Of Dental Sciences |
| Address |
Department of Periodontics,NH 16,Near HP Petrol Pump, Rajanagaram,Rajamahendravaram.
Department of Periodontics,NH-16,Near HP Petrol Pump, Rajanagaram,Rajamahendaravaram
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9052120645 |
| Fax |
|
| Email |
dhaliya2011@gmail.cam |
|
|
Source of Monetary or Material Support
|
| Self funded, Lenora Institute of Dental Sciences,Department of Periodontics,NH-16,Petrol Pump,Rajanagaram,Rajamahendravaram, Andhra pradesh, India,Pin code:533294 |
|
|
Primary Sponsor
|
| Name |
KSravani |
| Address |
Department of Periodontics,NH-16,Near HP Petrol Pump, Rajanagaram,Rajamahendravaram,Andhra pradesh,India.
Pincode :533294 |
| Type of Sponsor |
Other [Uddandi Surya Priyanka] |
|
|
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 |
| DrSravani Korukonda |
Lenora Institute Of Dental Sciences |
Department Of Periodontics,2nd floor,Room No-5,NH-16,NEAR HP PetrolPump,Rajanagaram,Rajamahendravaram.
East Godavari
ANDHRA PRADESH |
8309397729
0883-2484493
korukondasravani08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CHRONIC PERIODONTITIS PATIENTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age range 30 - 60 years |
|
| ExclusionCriteria |
| Details |
pregnant or lactating women
type 1 or 2 diabetes mellitus
history of tobacco usage
allergic to hydrogen peroxide or tray materials
presence of systemic diseases affecting healing or immune response |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate the clinical efficacy of perio protect method at baseline and after 1 month |
evaluate the clinical efficacy of perio protect method at baseline and after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| perio protect method as adjunctive to non surgical treatment in managing chronic periodontitis |
baseline,1month |
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="1"
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
|
periodontitis is a chronic inflammatory disease effecting the supporting structures of the teeth,is commonly managed with scaling and root planing (srp) though srp alone may not always achieve optimal results. This study assessed effectiveness of the perio protect method, which involves the subgingival delivery of 1.7% hydrogen peroxide gel combined with doxycycline 50mg/ml via customized trays. Patient underwent initial examination ,srp and impressions for tray fabrication, followed by daily application of the medicated gel for 15-20 minutes over 30 days after one month significant improvements were observed in clinical parameters including probing pocket depth ,gingival inflammation ,plaque index and bleeding on probing compared to baseline .the perio protect method effectively enhances periodontal therapy by targeting microbial biofilm and reducing inflammation through localised sustained drug delivery. |