| CTRI Number |
CTRI/2019/10/021752 [Registered on: 22/10/2019] Trial Registered Prospectively |
| Last Modified On: |
16/10/2019 |
| 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 Study to Compare and
evaluate the effect of one sided gum surgery alone or in combination with Component of blood (PRF) in bony defects associated with gum disease.
|
|
Scientific Title of Study
|
A clinical and radiographic evaluation of modified single buccal flap approach and its coronal respositioning with and without platelet rich fibrin (PRF) in periodontal intrabony defects- A double blind randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Omkumar Baghele |
| Designation |
Professor and PG Guide |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
MIDSR Dental College MIT Campus Ambajogai Road Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9321019946 |
| Fax |
02382228063 |
| Email |
drom94@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saleem khan |
| Designation |
Post Graduate Student |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
Department of Periodontology and Oral Implantology
MIDSR DENTAL COLLEGE and HOSPITAL vishwanathpuram
Ambajogai road LATUR
Latur
MAHARASHTRA
413512
India |
| Phone |
8421599981 |
| Fax |
02382228063 |
| Email |
salim0007dx15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omkumar Baghele |
| Designation |
Professor and PG Guide |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
MIDSR Dental College MIT Campus Ambajogai Road Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9321019946 |
| Fax |
02382228063 |
| Email |
drom94@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self supported. Monetary support from the investigators and material support from MIDSR dental college. |
|
|
Primary Sponsor
|
| Name |
MIDSR Dental college |
| Address |
MIDSR Dental College MIT Medical College Campus Ambajogai Road Latur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Saleem khan |
Department of Periodontology and Oral Implantology, MIDSR DENTAL COLLEGE |
MIDSR Dental College MIT Medical College Campus Ambajogai Road Latur
Latur
MAHARASHTRA |
8421599981
salim0007dx15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MIDSR Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, Periodontitis (osseous defects), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Single buccal flap alone in treatment of periodontal intrabony defects. |
| Intervention |
Group B |
Single buccal flap with platelet rich fibrin in treatment of periodontal intrabony defects |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with localized or generalized chronic periodontitis as per American
Academy of Periodontology International Workshop for Classifications of
Periodontal Disease 1999.
2. Subjects having acceptable systemic health.
3. Intrabony defect in both maxillary or mandibular region.
4. Patients having at least one intrabony defect more than or equal to 3 mm along with attendant pocket depth more than or equal to 5mm.
5. Absence of overt clinical inflammation at the time of surgery.
6. Patient signing written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients.
2. With unacceptable oral hygiene (Plaque index>2)
3. With any metabolic disease or endocrine disease having direct or indirect influence on
Bone healing.
4. With any periapical pathology associated with endodontic infection in the region of
Interest.
5. Patient on active orthodontic treatment.
6. Patient having >4 mm pocket in selected tooth on mid oral or palatal aspect, requiring
Buccal as well as oral flap for access.
7. Pregnant and lactating women.
8. Presence of defective prosthesis in the area of interest.
9. Subjects who are smokers and consume tobacco in any form.
10. Patient who are using drugs that may cause gingival enlargement, those allergic or sensitive to any medications that will be used in the study.
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing depth, Clinical attachment level
Radiographic bone fill
|
At 3 month and at 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival marginal level, plaque index, gingival index |
At 3month and at 6 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
10/12/2019 |
| 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="1"
Months="8"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Once the trial is over the study will be sent for consideration for publication in a periodontology
PubMed indexed journal
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
periodontitis is an infectious disease that causes destruction of tooth attachment apparatus .untreated periodontitis results in progressive attachment loss that may eventually lead to early tooth loss. single buccal flap approach by Trombelli may be a suitable technique which is not investigated thoroughly in the treatment of periodontal intrabony defect. It is a minimally invasive surgical procedure designed for reconstructive therapy of interasseous defect.An intrabony defect is a periodontal defect is within the bone surrounded by one ,two ,or three bony walls or combination thereof. Ultimate goal of periodontal therapy is regeneration .periodontal regeneration refers reproduction or reconstruction of lost or injured part in which architecture and function of thee lost or injured tissues are completely restored.platelets can play a crucial role in periodontal in regeneration as they are the reservoir and of growth factors and cytokines which are the key factor for regeneration of bone and maturation of soft tissue. so the platelets rich fibrin will help in treatment of intrabony defect. so the aim of present study is to evaluate the efficacy of single buccal flap approach and coronal repositioning with and without PRF in treatment of intrabony defect. |