| CTRI Number |
CTRI/2024/02/063326 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effects of argyreia speciosa gel and non eugenol periodontal dressing on tissue response, wound healing and pain following periodontal flap surgery |
|
Scientific Title of Study
|
Comparison of effect of topical application of argyreia speciosa gel and non-eugenol periodontal dressing on tissue response, wound healing, and pain following periodontal flap surgery – a split mouth randomized clinical study |
| 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 Vaishali Kisan Lihe |
| Designation |
Post graduate student |
| Affiliation |
S.M.B.T.Dental College and Hospital, Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT
Dental College and Hospital Sangamner
-
Ahmadnagar
MAHARASHTRA
421608
India |
| Phone |
9518926055 |
| Fax |
|
| Email |
lihevaishali29@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
421608
India |
| Phone |
9325596570 |
| Fax |
|
| Email |
dr.saurabh.subhash.patil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Kisan Lihe |
| Designation |
Post graduate student |
| Affiliation |
S.M.B.T.Dental College and Hospital, Sangamner |
| Address |
G-02 Department of periodontology and oral implantology, SMBT
Dental College and Hospital Sangamner
-
Ahmadnagar
MAHARASHTRA
421608
India |
| Phone |
9518926055 |
| Fax |
|
| Email |
lihevaishali29@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.M.B.T.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 Vaishali Lihe |
S.M.B.T.Dental College and Hospital, Sangamner |
G-O2 Dapartment of periodontology and oral implantology, S.M.B.T.Dental College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA |
9518926055
lihevaishali29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental collage, 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 will also given to the patient to apply at home twice daily for 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. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with moderate to severe chronic
periodontitis
2.Periodontal pockets greater than or equal to five mm.
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)Smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early wound healing, post operative pain perception will be assess |
base line to 2 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
07/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published under the Journal of Pharmacy and Bioallied Sciences (Pubmed cetral)
|
|
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 - Anyone
- 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 [lihevaishali29@gmail.com].
- For how long will this data be available start date provided 01-05-2024 and end date provided 30-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - -
|
|
Brief Summary
|
Aim of this study is to comparison of effect of topical application of argyreia speciosa gel and non-eugenol periodontal dressing on tissue response, wound healing, and pain following periodontal flap surgery – a split mouth randomized clinical study. 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, randomisation and quadrant allotment for either Topical application of Argyreia speciosa 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, Argyreia speciosa gel will be applied 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 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 1 week and healing index (HI) after 1st, 2nd week and VAS after 1st and 2nd week will be recorded as per the guidelines given by Lorenzo Marini et al, Landry et. al. (1988 ) and Faezeh Ghaderi et al respectively by second blinded operator. |