| CTRI Number |
CTRI/2019/09/021156 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect of microsurgery over conventional method in patients with periodontitis . |
|
Scientific Title of Study
|
“Clinical assessment of Open flap debridement using magnifying loupes and surgical operating microscope –A split mouth comparative study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Jaswitha |
| Designation |
Post graduate student |
| Affiliation |
Vishnu dental college |
| Address |
Department of periodontics and Implantology
Vishnu dental college Bhimavaram
Block 2
Room No 7
Department of periodontics and Implantology
Vishnu dental college
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8790994930 |
| Fax |
|
| Email |
vinthajaswitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohan kumar P |
| Designation |
Reader |
| Affiliation |
Vishnu dental college |
| Address |
Department of periodontics and Implantology
Vishnu dental college Bhimavaram
Block 2
Room No 7
Department of periodontics and Implantology
Vishnu dental college
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohan kumar P |
| Designation |
Reader |
| Affiliation |
Vishnu dental college |
| Address |
Department of periodontics and Implantology
Vishnu dental college Bhimavaram
Block 2
Room No 7
Department of periodontics and Implantology
Vishnu dental college
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vishnu dental college |
| Address |
Room no 7
block 2
Vishnu dental college
vishnupur
bhimavaram |
| Type of Sponsor |
Other [] |
|
|
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 |
| VJaswitha |
Vishnu Dental College |
Block 2
room 7
Vishnu dental college
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH |
8790994930
vinthajaswitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu Ethical Institutional Committee |
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 |
| Comparator Agent |
Periodontal flap surgery under surgical loupes |
Periodontal flap surgery under surgical loupes with magnification of 3.5X |
| Intervention |
Periodontal flap surgery under surgical operating microscope |
periodontal flap surgery performed under surgical operating microscope |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having moderate to severe periodontitis.
2.Systemically healthy patients
3.Persistence of probing pocket depth ≥ 5mm in at least 3 teeth in more than one sextant after Phase I therapy
|
|
| ExclusionCriteria |
| Details |
1.Patients who are known diabetics.
2.Pregnant patients.
3.History of any periodontal surgery done prior to the 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 |
1.Bleeding index (BI).
2.Early Wound healing index (EHI).
3.Probing pocket depth (PPD).
4.Clinical attachment level (CAL).
|
1.bleeding index after 3 months and 6 months
2.Early wound healing index after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ergonomic benefit to the clinician. |
18/7/2020 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
10/09/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized parallel clinical trial was planned to be done to evaluate the efficacy of magnification during periodontal therapy including the ergonomic benefits of clinician . |