| CTRI Number |
CTRI/2023/12/060633 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative evaluation of two less traumatic surgical approaches for the treatment of bony defects. |
|
Scientific Title of Study
|
Comparative evaluation of the treatment outcome of entire papilla preservation technique and modified-minimally invasive surgical technique in intrabony defect: a double blinded randomised controlled 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 Sasidharan G |
| Designation |
Post Graduate |
| Affiliation |
Karpaga vinayaga institute of dental sciences. |
| Address |
Room no.37,
Third floor,
Department of periodontology,
Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9626709608 |
| Fax |
|
| Email |
sasiperiokids@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniz A |
| Designation |
Professor and Head of the department. |
| Affiliation |
Karpaga vinayaga institute of dental sciences. |
| Address |
Room no.37,
Third floor,
Department of periodontology,
Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9884233240 |
| Fax |
|
| Email |
anizmds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniz A |
| Designation |
Professor and Head of the department. |
| Affiliation |
Karpaga vinayaga institute of dental sciences. |
| Address |
Room no.37,
Third floor,
Department of periodontology,
Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
09884233240 |
| Fax |
|
| Email |
anizmds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk), |
|
|
Primary Sponsor
|
| Name |
Dr Sasidharan G |
| Address |
Room no.37,
Third floor,
Department of periodontology,
Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk),
|
| 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 Sasidharan G |
Karpaga vinayaga Institute of dental sciences. |
Room no.37,
Third floor,
Department of periodontology,
Karpaga vinayaga Institute of dental sciences,
Gst road, chinna kolambakkam,
Palayanoor (po),
Chengalpattu (dt) 603308
Madhuranthagam(tk),
Kancheepuram
TAMIL NADU |
9626709608
sasiperiokids@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee – Karpaga vinayaga institute of dental sciences |
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 |
Entire papilla preservation surgical technique, osseograft-bone graft. |
A novel modified tunnel surgical technique designed to maintain the integrity of the interdental papilla is presented with the aim of providing an optimal environment for wound healing in regenerative procedures.
High-purity type-I collagen derived from bone is essential for tissue regeneration and remodeling in any osseous defect. Xenograft material (dmbm) is one such demineralized bone-derived type I collagen.
The time taken to complete this procedure is 1 hour, and follow-up is 6 months.
|
| Comparator Agent |
Modified-minimally invasive surgical technique, osseograft-bone graft. |
The modifiedâ€minimally invasive surgical technique (mâ€mist) has been proposed to reduce invasivity and patient side effects and to increase the odds for primary closure of the wound and for blood clot stability.
High-purity type-I collagen derived from bone is essential for tissue regeneration and remodeling in any osseous defect. Xenograft material (dmbm) is one such demineralized bone-derived type I collagen.
The time taken to complete this procedure is 1 hour, and follow-up is 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of two or more intra-bony defects, average probing pocket depth (PPD)
Between 5-8mm, average clinical attachment level (CAL) between 5-10mm, radiographic depth≥4mm
|
|
| ExclusionCriteria |
| Details |
Defects involving lingual sites, patients with a history of systemic conditions that affect the periodontium, smokers |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate and compare the use of the entire papilla preservation technique and the modified-minimally invasive surgical technique in the management of intrabony osseous defects. |
Baseline,3 Months,6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To radiographically evaluate & compare the use of the entire papilla preservation technique & modified minimally invasive surgical technique in the management of intrabony osseous defects. |
Baseline,3 Months,6 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/01/2024 |
| 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="8"
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 - NO
|
|
Brief Summary
|
THE AIM OF THIS RANDOMIZED CLINICAL
TRIAL (RCT) IS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC EFFECTIVENESS OF
ENTIRE PAPILLA PRESERVATION SURGICAL TECHNIQUE (EPP) TO MODIFIED MINIMALLY
INVASIVE SURGICAL TECHNIQUE (M-MIST) IN THE TREATMENT OF PERIODONTAL INTRAOSSEOUS
DEFECTS IN STAGE III PERIODONTITIS PATIENTS METHODOLOGY OF THIS STUDY IS TOTAL
NUMBER OF THIRTY PATIENTS (30–60) YEARS OLD SUFFERING FROM STAGE III
PERIODONTITIS WERE RECRUITED, ASSIGNED AND ALLOCATED RANDOMLY TO ONE OF TWO
GROUPS, GROUP A (INTERVENTION GROUP) TO RECEIVE ENTIRE PAPILLA PRESERVATION
TECHNIQUE (EPP) AND GROUP B (CONTROL GROUP) TO RECEIVE MODIFIED MINIMALLY
INVASIVE SURGICAL TECHNIQUE (M-MIST). EACH PATIENT PRESENTED INTRA-BONY
DEFECTS: THE SELECTED SITES WERE DIVIDED RANDOMLY INTO TWO TREATMENT GROUPS.
CLINICAL ATTACHMENT LEVEL GAIN (CAL GAIN) WAS RECORDED AS PRIMARY OUTCOME AND
RECALL APPOINTMENTS WERE CARRIED OUT AT 3 AND 6-MONTHS POST OPERATIVELY.
RADIOGRAPHICAL PARAMETERS WERE EVALUATED PRESURGICALLY AND AFTER 3 AND 6
MONTHS. |