CTRI Number |
CTRI/2023/11/059834 [Registered on: 14/11/2023] Trial Registered Prospectively |
Last Modified On: |
25/11/2024 |
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 and radiographic trial to study the treatment outcomes for bony defects using autograft VS combination of demineralized bone matrix and autograft. |
Scientific Title of Study
|
Comparative evaluation of the treatment outcomes for intrabony vertical defects by intra oral osseous autograft vs demineralized bone matrix and intra oral free osseous autograft- a clinical and radiographic evaluation. |
Trial Acronym |
NILL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sakshi Kanherkar |
Designation |
Post Graduate student |
Affiliation |
SMBT Dental College and Hospital |
Address |
G 02, Department of Periodontics, SMBT Dental and Hospital Ghulewadi, Sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
9870531997 |
Fax |
|
Email |
sakshik0305@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Purushottam Rakhewar |
Designation |
HOD, Proffesor and Guide |
Affiliation |
SMBT Dental College And Hospital |
Address |
G 02, Department of Periodontics, SMBT Dental and Hospital Ghulewadi, Sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
939370017343 |
Fax |
|
Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sakshi Kanherkar |
Designation |
Post Graduate Student |
Affiliation |
SMBT Dental College and Hospital |
Address |
G 02, Department of Periodontics, SMBT Dental and Hospital Ghulewadi, Sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
9870531997 |
Fax |
|
Email |
sakshik0305@gmail.com |
|
Source of Monetary or Material Support
|
G 02, Department of Periodontics, SMBT Dental and Hospital, Ghulewad, Sangamner |
|
Primary Sponsor
|
Name |
NONE |
Address |
NONE |
Type of Sponsor |
Other [NONE] |
|
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 Sakshi Kanherkar |
SMBT Dental college and hospital |
G-02, Department of periodontics Ahmadnagar MAHARASHTRA |
9870531997
sakshik0305@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
COMMITTEE ON ETHICS SMBT DENTAL COLLEGE SANGAMNER |
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 |
Autograft |
Autograft from intra oral sites will be procured for treatment of intrabony vertical defects and follow up will be done at 3 months and 6 months |
Comparator Agent |
Combination of Demineralized Bone matrix and autograft |
Both demineralized bone matrix and autograft in combination will be placed in the vertical defect and follow up will be done at 3 months and 6 months |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1.PRESENCE OF PERIODONTITIS WITH VERTICAL INTRABONY DEFECT HAVING PROBING POCKET DEPTH PPD MORE THAN OR EQUAL TO 5 MM, RADIOGRAPHIC DEFECT DEPTH MORE THAN OR EQUALTO 3MM AFTER PHASE I THERAPY.
2.ABSENCE OF ANY ANATOMICAL LIMITATIONS.
3.PATIENT WILLING TO UNDERGO SURGERY AND READY TO GIVE WRITTEN CONSENT.
|
|
ExclusionCriteria |
Details |
1) Patients with systemic diseases, smokers and pregnant and lactating women.
2) Individuals with unacceptable oral hygiene.
3) Patients contraindicated for periodontal surgery.
4) Patients undergone periodontal therapy for past 6 months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
COMPARE REDUCTION IN PROBING DEPTH FOR INTRABONY VERTICAL DEFECTS |
Baseline to 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
NONE |
NONE |
|
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)
|
01/01/2024 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshik0305@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 01-10-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Aim of the study is to compare the treatment outcomes for
intrabony vertical defects using autogenous bone graft alone and combination of
demineralized bone matrix and autogenous bone graft. All participants will be
explained about the need and design of the study. Informed consent will be
obtained from the patients. Through clinical case history will be
recorded. Each patient will undergo ultrasonic scaling (EMS) by a single
operator. All clinical parameters (GI, PI, PPD, CAL, BOP) will be recorded using
UNC15 periodontal probe (Hu Friedy ) at baseline, 3 months and 6 months
interval. It is a single blind study in which the patient will be randomly
assigned to either autogenous bone graft group (control) or combination of
demineralized bone matrix and autogenous bone graft group (test) using manual
lottery method. After allotment of the groups following surgical method will be
performed. . Intraoral antisepsis will be performed with 10ml of 0.2%
chlorhexidine digluconate rinse and by a povidine iodine solution extra oral
antisepsis will be carried out. The site scheduled for surgery will be
anesthetized by appropriate local anesthesia. After administration of local anesthesia,
incisions will be made intracrevicularly through the bottom of the
pocket on both facial and the lingual/palatal as well as interdental area. Incision will be performed from distal to mesial aspect of
the area planned for the surgery. Mucoperiosteal flaps will be elevated beyond the mucogingival
junction in order to achieve primary closure in all cases irrespective of
groups. The marginal bone and diseased root surfaces will be exposed. Care will be taken to preserve as much interproximal soft tissue as
possible. Meticulous defect debridement and root planning will be carried out
using hand instruments and area-specific curettes in order to remove calculus,
necrotic cementum and granulation tissues. No osseous recontouring will be performed, similar
procedure will be performed for both control site and the test site. Control site will be treated with autogenous bone graft alone and test
site will be treated with autogenous bone graft and demineralized bone matrix. The piezo electric device will be used for bone removal
for autogenous bone grafting. It will placed directly into the recipient site. Autogenous bone graft of the required size will be procured by
extending the mucoperiosteal flap in the adjacent tooth area to cover the
osseous defect in the control group. Combination of ABG + DMM will be used to cover the
osseous defect in the test group. Mucoperiosteal flaps will be repositioned and secured
in place using non-absorbable black silk suture. The interrupted sutures will be placed. The surgical area will be protected and covered with
periodontal dressing. The following post operative care will be given to the
patients Sutures will be removed after 7-10 days postoperatively. Antibiotics & Analgesics will be prescribed. Each patient will be instructed for proper oral hygiene measure at
each appointment. Patients will be instructed to avoid using toothbrush at the
surgical site. Teeth cleaning will be initiated with gentle brushing using soft
brush after suture removal. All clinical parameters will be re-evaluated 3 months and 6
months after surgery by second blinded operator. Radiographic parameters will
be re-evaluated 6 months after surgery. |