| CTRI Number |
CTRI/2026/04/107298 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Ozonated Olive Oil and Photodynamic Therapy Along with Deep Cleaning in Patients with Gum Disease |
|
Scientific Title of Study
|
Comparative Evaluation of The Effectiveness of Ozonated Olive Oil and Photodynamic Therapy as an Adjunct to Scaling and Root Planning in Treatment of Patients with Stage II or III Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhisikta Biswal |
| Designation |
Post Graduate Student, Department of Periodontics |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
| Address |
Department of Periodontology, First Floor, Room 04, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439764635 |
| Fax |
|
| Email |
2489026@kids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhirendra Kumar Singh |
| Designation |
Professor, Department of Periodontics |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
| Address |
Department of Periodontology, First Floor, Room 04, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8895910320 |
| Fax |
|
| Email |
dr.dhirendra27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHISIKTA BISWAL |
| Designation |
Post Graduate Student, Department of Periodontics |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
| Address |
Department of Periodontology, First Floor, Room 04, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439764635 |
| Fax |
|
| Email |
2489026@kids.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhiskta Biswal |
| Address |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Patia, Bhubaneswar |
| 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 |
| DR ABHISIKTA BISWAL |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
Department of Periodontology, First Floor, Room 04, Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Patia, Bhubaneswar
Khordha
ORISSA |
9439764635
2489026@kids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences (KIMS), KIIT Deemed to be University, Bhubaneswar |
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 |
| Intervention |
Ozonated Olive Oil |
Topical application of ozonated olive oil into periodontal pockets immediately after scaling and root planning using a syringe with a blunt needle. The oil is applied to ensure adequate subgingival delivery covering the entire pocket depth. |
| Intervention |
Photodynamic Therapy |
Application of photosensitizer like methylene blue into periodontal pockets followed by activation using a low level diode laser of appropriate wavelength as per manufacturer’s instructions, immediately after scaling and root planning. |
| Comparator Agent |
Scaling and Root Planning |
Full mouth scaling and root planning performed using ultrasonic scalers and hand instruments for removal of supra gingival and subgingival plaque and calculus. Treatment performed in a single session under aseptic conditions. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age of the patient should be between 20 years to 60 years
Systemically healthy patients
Patients diagnosed with Aggressive Periodontitis
Stage II and III Periodontitis (American Academy of Periodontology and European Federation of Periodontology 2017)
Patients having probing pocket depth (PPD) greater than or equal to 5 mm
Patients who had not taken antibiotics within 6 months
Patients with horizontal bone loss in orthopantogram (OPG)
Willingness to comply with the study protocol and follow-up visits
|
|
| ExclusionCriteria |
| Details |
Patient who went through scaling in the last 6 months
Patient who went through scaling in the last 6 months
Stage I Periodontitis (American Academy of Periodontology and European
Federation of Periodontology)
Lactating or Pregnant females.
Patients who are current users of any mouth rinses
Patients who have undergone periodontal surgery within the last 6 months
Patients using antibiotics or anti inflammatory medications within the last 3 months
Patients with systemic diseases that could affect periodontal health (for example
diabetes, cardiovascular diseases)
Inability to participate & follow up procedures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in Probing Pocket Depth (PPD in mm) and gain in Clinical Attachment Level (CAL in mm) at treated sites following intervention (SRP alone vs SRP with Ozonated Olive Oil vs SRP with Photodynamic Therapy) |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of sites with Bleeding on Probing (BOP)
Mean Plaque Index (Silness and Löe score)
Mean Gingival Index (Löe and Silness score) |
Baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/04/2026 |
| 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="3"
Months="0"
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
|
This study is a randomized comparative clinical trial evaluating the effectiveness of ozonated olive oil and photodynamic therapy (PDT) as adjuncts to scaling and root planing (SRP) in patients with Stage II and Stage III periodontitis
A total of 60 systemically healthy patients will be divided into three groups
-
Group A: SRP alone
-
Group B: SRP with ozonated olive oil
-
Group C: SRP with photodynamic therapy
Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline, 1 month, 3 months, and 6 months.
The study aims to determine which adjunctive therapy provides superior clinical improvement in periodontal health, thereby helping to optimize non surgical periodontal treatment protocols. |