| CTRI Number |
CTRI/2020/04/024645 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of chitosan as periodontal dressing following periodontal flap surgery |
|
Scientific Title of Study
|
"Comparativce evaluation of gingival tissue response following placement of chitosan and a non-eugenol dressing after periodontal flap surgery:A comparative clinical study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavani |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room.no:03,Departmengt of periodontology,GDCRI,
Victoria hospital premises,Fort
Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
nandini.kodanna786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnima Bandari |
| Designation |
Assistant professor |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room.no-03,department of periodontology,GDCRI,
Victoria hospital premises,
Fort,Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
drpurnimabhandari321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavani |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and research institute, Bangalore |
| Address |
Room.no:03,Departmengt of periodontology,GDCRI,
Victoria hospital premises,Fort
Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
nandini.kodanna786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhavani
Room.no:03,Department of periodontology,GOvt dental college and research institute,Victoria hospital premises,Bangalore-560002 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavani |
| Address |
Bangalore medical college ladies hostel,opp.tippu palace,victoria hospital premises,Bangalore-560002 |
| 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 Bhavani |
Govt.dental college and research institute ,Bangalore |
Room.no:03,Department of periodontology,GDCRI,
Victoria hospital premises,Bangalore-560002
Bangalore
KARNATAKA |
9986156609
nandini.kodanna786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Govt.dental college and research institute,Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
subjects with chronic periodontitis indicated for flap surgery |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan |
Placement of chitosan over the the periodontal flap,single application soon after the flap surgery and will be left over the surgical site for one week |
| Comparator Agent |
non eugenol dressing |
placement of non eugenol dressing over periodontal flap ,single application soon after the flap surgery and will be left over the surgical site for one week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
i.subjects with generalized probing depth of >5mm reqyuiring periodontal flap surgery in atleast two different quadrants.
ii.systematically healthy |
|
| ExclusionCriteria |
| Details |
i.subjects who have undergone periodontal surgery in the past one year.
ii.pregnant and lactating mothers.
iii.subjects with tobacco in any forms and alcoholics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of gingival tissue response following placement of chitosan and non eugenol dressing after periodontal flap surgery. |
on 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patient comfort as evaulated by patient assessment quesstionnaire. |
on 7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
20/04/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a comparative clinical study which aims to compare the gingival tissue response following placement the chitosan and a non eugenol dressing after periodontal flap surgery. Chitosan is natural biodegradable product with various bioactive properties like antimicrobial properties, hemostatic activity,tissue regenerative capacity,osteeoconductivity. However,Chitosan has not been tried as a periodontal dressing material till date. |