| CTRI Number |
CTRI/2025/12/098502 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the 3 months benefits of topical and oral use of Coenzyme Q10 in treating chronic periodontitis patients |
|
Scientific Title of Study
|
Clinical Evaluation of Effects of Adjunctive Use of Topical and Systemic
Administration of Coenzyme Q10 in Non- Surgical Periodontal Therapy: A
Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-9097 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anisha Rani |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room no 5, Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant
Dehradun Uttarakhand
Dehradun UTTARANCHAL 248140 India |
| Phone |
9131634152 |
| Fax |
|
| Email |
anisharani99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Aaron F Gomes |
| Designation |
PG Guide, Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant
Dehradun Uttarakhand
Dehradun UTTARANCHAL 248140 India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anisha Rani |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room no 5, Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant
Dehradun Uttarakhand
Dehradun UTTARANCHAL 248140 India |
| Phone |
9131634152 |
| Fax |
|
| Email |
anisharani99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anisha Rani |
| Address |
Room no 5,Department of Periodontology and Oral Implantology,
Uttaranchal Dental and Medical Research Institute,
Mazri Grant, Dehradun, Uttarakhand, India. 248140 |
| 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 Anisha Rani |
Uttaranchal Dental and Medical Research Institute |
Room No 5,
Department of
Periodontology and
Oral Implantology,
Uttaranchal Dental And
Medical Research
Institute, Majri Grant,
Dehradun, Uttarakhand Dehradun UTTARANCHAL |
9131634152
anisharani99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC UDMRI |
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 |
Coenzyme Q10 as local irrigation and dentifrice with scaling and root planing in stage II periodontitis patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Then the pockets will be irrigated with normal saline and then dried with absorbent paper points. CoQ10 gel will be delivered intrasulcularly. No softgel capsules of CoQ10 will be given to these participants. Only the dentifrice containing CoQ10 will be given to these
participants. Participants will be observed at baseline, 1 month and 3 months |
| Intervention |
Coenzyme Q10 as local irrigation, oral administration and dentifrice with scaling and root planing in stage II periodontitis patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. The pockets will be irrigated with normal saline. The pockets will be dried sufficiently and then the solution will be delivered intrasulcularly at those sites. The participant will be given 30 softgel capsules of CoQ10 and asked to take one softgel every day. Also, a tube of dentifrice containing CoQ10 will be handed over to the participants. Participants will be observed at baseline, 1 month and 3 months |
| Comparator Agent |
Scaling and root planing with daily use of regular dentifrice not containing Coenzyme Q10 in stage II periodontitis patients. |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Then the pockets will be irrigated with normal saline. No
CoQ10 intrasulcular application will be done. No softgel capsules nor any
dentifrice containing CoQ10 will be given. A standard dentifrice tube not
containing CoQ10 will be given to be used twice daily. Participants will be observed at baseline, 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients diagnosed with stage II periodontitis
2. having more than two non-adjacent sites with probing pocket depth (PPD) of more than or equal to 4mm and less than or equal to 5mm and clinical attachment loss (CAL) of 3-4 mm
3. having at least 6 teeth in any arch, not including the third molar
4. systemically healthy Indian patient
5. ready to come for 3-month recall |
|
| ExclusionCriteria |
| Details |
1. presence of periapical or pulpal infections on qualifying teeth
2. requiring regular warfarin therapy
3. diagnosed with bile duct obstruction
4. prescribed chemotherapeutic drugs
5. taking any supplement of anti-oxidants for another condition
6. patients averse to taking medications that are not suitable to vegetarians
7. history of hypersensitivity to excipients that are present in CoQ10
dentifrice
8. history of sudden hypoglycaemic episodes
9. oral conditions requiring emergency treatment
10. periodontal conditions indicated for surgical intervention
11. lack of motivation and/or non-compliance to oral hygiene
12. moderate/heavy smoking or any other form of tobacco addiction
13. uncontrolled diabetes mellitus
14. undergoing orthodontic treatment
15. pregnancy and lactation
16. chronic alcohol consumption
17. history of immunocompromised status
18. received scaling, root planing and polishing within 4 months prior to study
19. had periodontal surgery within 6 months prior to study
20. use of systemic or subgingival antimicrobials microbials within 6 months prior to baseline examination
21. ongoing drug therapy that could affect the clinical features of periodontitis or the response to periodontal treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Attachment Level. |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Index, as described by Silness & Löe (1964) |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
| Gingival index as described by Löe & Silness (1963) |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
| Bleeding on probing (BOP) as described by Lang et al., (1990) |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
| Probing Pocket Depth |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
| Relative Attachment Level. |
1.at baseline;
2.at 4 weeks;
3.at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="69" Sample Size from India="69"
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)
|
16/12/2025 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Title of the Research Proposal: CLINICAL EVALUATION OF EFFECTS OF ADJUNCTIVE USE OF TOPICAL AND SYSTEMIC ADMINISTRATION OF COENZYME Q10 IN NON- SURGICAL PERIODONTAL THERAPY: A RANDOMIZED CONTROLLED TRIAL.
Aim: To clinically evaluate and compare periodontal parameters like plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment levels over a follow-up period of 3 months, in a cohort of stage II periodontitis patients who have been randomized into three treatment groups; a group of participants who will receive non-surgical periodontal therapy (NSPT) consisting of scaling and root planing (SRP), Coenzyme Q10 (CoQ10) intrasulcular application, CoQ10 oral supplements and daily use of CoQ10.
Materials and methods: A cohort of 69 participants who are presenting with stage II periodontitis will be selected from the out-patients visiting the department and an informed consent will be administered. The participants will be randomized into three groups, For the participants allotted to Test Group 1: soon after completion of SRP, the pockets will be irrigated with normal saline such that there is no debris and any blood clots remaining in pockets. The pockets will be dried sufficiently using blunted absorbent paper points. CoQ10 gel will be aspirated into a disposable syringe and then the solution will be delivered intrasulcularly at those sites which are having PPD of more than or equal to 4mm and less than or equal to 5mm and CAL of 3-4 mm. The needle of the syringe will be placed parallel to the long axis of the tooth and gently inserted up to 1mm less than the depth of the pocket. The plunger will be pressed with delicate force such that the gel extrudes out of the syringe tip at the depth of pocket slowly. The syringe will be slowly withdrawn from the pocket as the plunger will be pushed and the gel will be flooding the pocket at where the needle tip will be located until it will be totally out of pocket confines. No force will be applied on the pocket externally. The participant will be asked not to rinse her/his mouth for a period of half hour thereafter. She/he will be told not to eat any food or drink any fluid for 2 hours after the intrasulcular application. The participant will be given 30 softgel capsules of CoQ10 and asked to take one softgel along with water soon after dinner, every day for next 30 days. Also, a tube of dentifrice containing CoQ10 will be handed over to the participants and they will be asked to use only that dentifrice and no other toothpaste for their daily twice a day oral hygiene routine for next 3 months. At the end of 1 month, she/he will be asked to report back to the clinic and after recording the timepoint ‘t1’ scores she/he will be handed a further 60 CoQ10 softgel capsules and 2 tubes of dentifrice containing CoQ10 for daily oral supplementation and twice-daily oral hygiene for next 60days. The participant will return for follow-up at timepoint ‘t3’, i.e. 3- months after intrasulcular application of CoQ10. For the participants allotted to Test Group 2: soon after completion of SRP, the pockets will be irrigated with normal saline so as to remove any debris/blood clots and then dried with absorbent paper points. CoQ10 gel will be delivered intrasulcularly in the same technique as in Test Group 1. No softgel capsules of CoQ10 will be given to these participants allotted to Test Group 2. Only the dentifrice containing CoQ10 will be given to these participants to be used in the same fashion as with Test Group 1. At the end of 1 month, the participant will be asked to report back to the clinic and after recording the timepoint ‘t1’ scores she/he will be handed a further 2 tubes of dentifrice containing CoQ10 twice-daily oral hygiene for next 60days. The participant will return for follow-up at timepoint ‘t3’, i.e. 3- months after intrasulcular application of CoQ10. For the participants allotted to Control Group: soon after completion of SRP, the pockets will be irrigated with normal saline so as to remove any debris. No CoQ10 intrasulcular application will be done. No softgel capsules nor any dentifrice containing CoQ10 will be given. A standard dentifrice tube not containing CoQ10 will be given to be used twice daily. The participants will be asked to return for follow-up after 30 days for checkup and recording of scores at time-point t1, and then again after 3-months from baseline for follow-up at time-point t3.
Data Analysis. The data will be analyses statistically with standard analysis of variance at a level of significance of p?0.05 |