| CTRI Number |
CTRI/2021/03/031989 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF CLINICAL AND RADIOGRAPHIC OUTCOMES OF NON INCISIED PAPILLA SURGICAL APPROACH AND MINIMAL INVASIVE SURGICAL TECHNIQUE IN INTRABONY DEFECTS. |
|
Scientific Title of Study
|
A CLINICAL AND RADIOGRAPHIC
COMPARATIVE EVALUATION OF THE
OUTCOMES OF NON-INCISED PAPILLAE
SURGICAL APPROACH AND MINIMALLY
INVASIVE SURGICAL TECHNIQUE IN THE
TREATMENT OF INTRABONY DEFECTS: A
RANDOMIZED CONTROLLED 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 |
Mili Patel |
| Designation |
Post graduate student |
| Affiliation |
Manubhai patel Dental College |
| Address |
Department of periodontology and implantology,
Manubhai Patel Dental College and Hospital
Vishajyoti Aashram
Near vishwanitri bridge Munjmahuda Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
9265773293 |
| Fax |
|
| Email |
milipatel6565@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Reader |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of periodontology and implantology,
Manubhai Patel Dental College and Hospital
Vishajyoti Aashram
Near vishwanitri bridge Munjmahuda Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
drpriya_n@mpdentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Reader |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Department of periodontology and implantology,
Manubhai Patel Dental College and Hospital
Vishajyoti Aashram
Near vishwanitri bridge Munjmahuda Vadodara
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
drpriya_n@mpdentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Manubhai patel dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Mili Patel |
| Address |
Department of Periodontology and Implantology
Manubhai Patel Dental College and Hospital
Vishwajyoti aashram
Near vishwamitri bridge Munjmahuda Vadodara |
| 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 |
| Mili Patel |
Manubhai patel Dental College |
Department of periodontology and implantology, Manubhai Patel
Dental College and Hospital Vishajyoti Aashram Near vishwanitri
bridge Munjmahuda Vadodara
Vadodara
Vadodara
GUJARAT |
9265773293
milipatel6565@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH |
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 |
Regenerative treatment of intra bony defect |
Regenerative treatment of intra bony defect by minimally invasive surgical technique |
| Comparator Agent |
Regenerative treatment of intra bony defect |
Regenerative treatment of intra bony defect by non invasive papilla preservation surgical approch |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with periodontitis,
According to World Workshop AAP and EFP
2017 latest classification
Periodontal lesions with pocket probing depth (PPD) > 5 mm
Intra bony defect > 3 mm
All patients complied fully with the study
protocol until the final evaluation |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases that
contraindicated treatment
Third molars
Teeth with incorrect endodontic or restorative
treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of this study is to compare the
clinical and radiographic outcomes of periodontal
regeneration of intraosseous defects by two
regenerative techniques using a marginal approach,
Minimally invasive surgical technique (MIST)or
an apical approach, Non-incised papillae surgical
approach (NIPSA) |
Baseline
3 months
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The aim of this study is to compare the
clinical and radiographic outcomes of periodontal
regeneration of intraosseous defects by two
regenerative techniques using a marginal approach,
Minimally invasive surgical technique (MIST)or
an apical approach, Non-incised papillae surgical
approach (NIPSA) |
Baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/03/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will arise from the results from the data tabulated from this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison and evaluation of the clinical and radiographic outcomes of periodontal regeneration of intraosseous defects by two regenerative techniques using a marginal approach, Minimally invasive surgical technique (MIST)or an apical approach, Non-incised papillae surgical approach (NIPSA) at baseline, 3and 6 months. |