| CTRI Number |
CTRI/2025/04/085848 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| 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 healing and pain relief effects of Elephant creeper, Turmeric, Triphala, and COE-PAK ®after periodontal flap surgery |
|
Scientific Title of Study
|
Comparing the effect of Argyreia speciosa gel, Curcumin gel, Triphala gel and non- eugenol periodontal dressing on wound healing and pain post periodontal flap surgery-A randomized clinical trial |
| 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 Soniya Arvind Waghmare |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Sangamner
Ahmadnagar
Maharashtra
422608
India
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7448026273 |
| Fax |
|
| Email |
soniyawaghmare1122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Patil |
| Designation |
Reader and PG guide |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Sangamner
Ahmadnagar
Maharashtra
422608
India
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9325596570 |
| Fax |
|
| Email |
dr.saurabh.subhash.patil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soniya Arvind Waghmare |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT Dental College and Hospital Sangamner
Ahmadnagar
Maharashtra
422608
India
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7448026273 |
| Fax |
|
| Email |
soniyawaghmare1122@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Sangamner Maharashtra, 422608 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Soniya Waghmare |
SMBT Dental College and Hospital, Sangamner |
G-02 Department of periodontology and oral implantology,
SMBT Dental College and Hospital, Sangamner
Ahmadnagar
Maharashtra
Ahmadnagar
MAHARASHTRA |
7448026273
soniyawaghmare1122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee On Ethics, SMBT Dental College,Sangamner |
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 |
Argyreia speciosa gel |
Argyreia speciosa gel will be applied immediately by the operator and also will be given to the patient to apply at home twice daily for the next 7 days. |
| Comparator Agent |
COE-PAK |
Will be applied by the operator immediately after surgery and will remain there for 7 days according to standard protocol |
| Intervention |
Curcumin gel |
Curcumin gel will be applied immediately by the operator and also will be given to the patient to apply at home twice daily for the next 7 days |
| Intervention |
Triphala gel |
Triphala gel will be applied immediately by the operator and also will be given to the patient to apply at home twice daily for the next 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with moderate to severe chronic periodontitis
2.Pocket probing depth greater than or equal to 5mm.
3.Systemically healthy patients fit for periodontal surgery
4.Patients with good oral hygiene maintenance |
|
| ExclusionCriteria |
| Details |
1.Patients with present or past systemic illnesses known to affect the outcomes of periodontal therapy.
2.Immunocompromised patients.
3.Patients taking medications that may interfere with periodontal therapy.
4.Pregnant patients.
5.Patient with any allergic tendencies pertaining to treatment.
6.Deleterious oral habits. (E.g. Smoking, alcohol consumption etc.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early wound healing, post operative pain perception will be assessed. |
first and second week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [soniyawaghmare1122@gmail.com].
- For how long will this data be available start date provided 15-05-2025 and end date provided 25-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Aim of this study
is to compare effect of Argyreia Speciosa gel, Curcumin gel, Triphala
gel and Non –eugenol periodontal dressing on wound healing and pain following
periodontal flap surgery-A randomized clinical trial. After obtaining
thorough case history and written informed consent from the patients enrolled
in the study (considering all inclusion and exclusion criteria) each patient
would undergo the required periodontal flap surgery. After the surgical
procedure, randomization and quadrant allotment for either Topical
application of Argyreia speciosa gel or Triphala gel or Curcumin gel or
non-eugenol periodontal dressing will be done. For periodontal dressing group,
COE-PAK will be mixed and applied, according to manufacturer instructions.
For Argyreia speciosa gel group, Triphala gel group and Curcumin gel
group, the gels will be applied to respective quadrants immediately
by the clinician and also will be given to the patient to apply as directed on
the operated site twice daily for the next 7 days. Patients failing to comply
with timely application of Argyreia speciosa gel, Triphala gel, Curcumin
gel as instructed will be excluded from the study. After 1 week the pack
and sutures will be removed by the same operator. Early Healing Score
(EHS) after 1st and 2nd week
and VAS after 1st and 2nd week will be
recorded by second blinded operator. The
time period between periodontal flap surgeries will be at least 3 weeks.
|