| CTRI Number |
CTRI/2024/10/075932 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the difference between bone splitting by piezo unit and bone penetration in localized bony defects in chronic periodontitis patients |
|
Scientific Title of Study
|
Comparative Evaluation between Osseous Bone Splitting by Piezosurgery and Intramarrow Penetration in Localized Intra-Bony Defects in Patients with Chronic Periodontitis: A Clinico-Radiographical 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 Manav Varshney |
| Designation |
Post Graduate Student |
| Affiliation |
Atal Bihari Vajpaypee Medical University |
| Address |
Department of Periodontology and Oral Implantology, Room no. 05
ITS Centre for dental studies and research, NH-34 Delhi-Meerut
road, Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9870857805 |
| Fax |
|
| Email |
manavkeytosuccess07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumit Malhotra |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpaypee Medical University |
| Address |
Department of Periodontology and Oral Implantology, Room no. 05
ITS Centre for dental studies and research, NH-34 Delhi-Meerut
road, Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9582355523 |
| Fax |
|
| Email |
sumitmalhotra@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manav Varshney |
| Designation |
Post Graduate Student |
| Affiliation |
Atal Bihari Vajpaypee Medical University |
| Address |
Department of Periodontology and Oral Implantology, Room no. 05, ITS Centre for dental studies and research, NH-34 Delhi-Meerut
road, Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
09870857805 |
| Fax |
|
| Email |
manavkeytosuccess07@gmail.com |
|
|
Source of Monetary or Material Support
|
| I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH, NH-34, DELHI- MEERUT
ROAD,MURADNAGAR,GHAZIABAD,UTTAR PRADESH,INDIA,201206 |
|
|
Primary Sponsor
|
| Name |
DR MANAV VARSHNEY |
| Address |
Department of Periodontology and Oral Implantology, Room no. 05
ITS Centre for dental studies and research, NH-34 Delhi-Meerut
road, Muradnagar, Ghaziabad, Uttar Pradesh, India,201206 |
| Type of Sponsor |
Other [STUDENT] |
|
|
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 MANAV VARSHNEY |
I.T.S CENTRE FOR DENTAL STUDIES AND RESEARCH |
DEPARTMENT OF
PERIODONTOLOGY
AND ORAL
IMPLANTOLOGY,
ROOM NO.05
Ghaziabad
UTTAR PRADESH |
09870857805
manavkeytosuccess07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Institutional Ethics 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 |
Intra marrow penetration with open flap Debridement |
The defect site will be penetrated by a round carbide bur of 1-mm diameter. IMP under saline irrigation will deep enough to ensure bleeding from the medullary cavity, and two to five perforations were made with 1-mm distance between each other in the osseous defect. The graft material will be placed in small increments with the help of an amalgam carrier. Each increment will be packed down adequately. The graft will be loaded up to the alveolar crest level.
Duration and frequency- once till the formation of bleeding points from medullary cavity |
| Intervention |
osseous bone piezo-splitting with Open Flap Debridement |
The proximal osseous wall will split using a piezoelectric unit under copious water irrigation 1 mm apical to the alveolar crest. Osseous wall splitting will extended apically up to the level of the defect base. The split bony wall will be tilted toward the periodontitis affected exposed root surface using piezo burs. Care would be taken not to induce extra force that could fracture the base of the split bony wall, especially for lower teeth with mostly compact bone at the most coronal third. The created V-shaped gap between adjacent-tooth bony wall and swaged bone will be filled tightly with the graft substitute.
Duration and frequency- once until it will 1 mm away from the periodontally affected exposed root surface |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged 30- 60 years.
2. 2 or 3 wall intra-bony interproximal defect around posterior teeth without furcation involvement.
3. Pocket probing depth ≥6 mm.
4. Intra-bony defects (IBD) measured from the Alveolar Crest to the base of the defect in diagnostic periapical radiographs of ≥3 mm, with a width of ≥3 mm at its most coronal region.
5. IBD with ≥45-degree angulation.
6. Positive informed consent with good patient compliance.
|
|
| ExclusionCriteria |
| Details |
1. Presence of periodontal treatment during the previous year.
2. Non- vital and mobile teeth.
3. Pregnant and lactating females.
4. Patients having systemic diseases.
5. History of smoking, alcohol, drug or tobacco abuse.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque index.
2. Gingival Index.
3. Pocket Probing Depth using acrylic stent.
4. Relative Attachment Level using acrylic stent.
|
At baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Relative Defect Base Level (DBL) measured from CEJ to Bottom of defect (BD).
2. Relative Crestal Bone Level (CBL) measured from CEJ to Alveolar Bone Crest (AC).
3. Radiographic Intrabony Defect Depth (INTRA) measured by subtracting CBL from DBL.
4. Radiographic Defect Angle (ANG) measured between the line tangential to the root surface and the second line connecting BD to AC.
|
At baseline and after 3 months. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to compare the efficacy of two techniques—osseous bone piezo-splitting and Intra Marrow Penetration (IMP)—in conjunction with Open Flap Debridement (OFD) for managing Localized Intra-Bony Defects (IBD) in patients with Chronic Periodontitis. Objectives are to- - Assess clinical parameters (Gingival Index, Plaque Index, Pocket Probing Depth, Relative Attachment Level) at baseline and after 3 months for both treatment groups:
- Group A: OFD with piezo-surgery
- Group B: OFD with IMP
- Evaluate radiographic parameters (Defect Base Level, Crestal Bone Level, Intrabony Defect Depth, Defect Angle) at the same intervals.
This comparative study will provide insights into the effectiveness of these treatment modalities in improving periodontal health. |