CTRI

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CTRI Number

CTRI/2024/04/066249 [Registered on: 24/04/2024] Trial Registered Prospectively

Last Modified On:

11/04/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia
Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

the effectiveness of bone graft alone versus when combined with adjuvant in management of bone cavity type irregularities in oral and maxillofacial region

Scientific Title of Study

The effectiveness of demineralized freezed dried bone allograft alone versus when combined with platelet rich fibrin in the management of cystic defects in oral and maxillofacial region

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 Rudragouda R
Designation	postgraduate
Affiliation	A J institute of dental science
Address	dr Rudragouda R postgraduate Dept. of Oral and Maxillofacial surgery A J Institute of dental sciences Kuntikana Mangalore dr Rudragouda R postgraduate Dakshina Kannada KARNATAKA 575004 India
Phone	9880244358
Fax
Email	rudragoudar05@gmail.com

Details of Contact Person
Scientific Query

Name	Dr U B Shabari
Designation	Reader
Affiliation	A J institute of dental science
Address	dr. U B shabari Reader Dept. of Oral and Maxillofacial surgery A J Institute of dental sciences Kuntikana Mangalore Karnataka dr. U B shabari Reader Dakshina Kannada KARNATAKA 575004 India
Phone	9449753802
Fax
Email	ubbhaskar24@gmail.com

Details of Contact Person
Public Query

Name	Dr U B Shabari
Designation	Reader
Affiliation	A J institute of dental science
Address	dr. U B shabari Reader Dept. of Oral and Maxillofacial surgery A J Institute of dental sciences Kuntikana Mangalore Karnataka Dr. U B shabari Reader Dakshina Kannada KARNATAKA 575004 India
Phone	9449753802
Fax
Email	ubbhaskar24@gmail.com

Source of Monetary or Material Support

A J institute of dental sciences mangaluru

Primary Sponsor

Name	Dr Rudragouda R
Address	Dept. of Oral and Maxillofacial surgery A J Institute of dental sciences Kuntikana Mangalore
Type of Sponsor	Other [individual]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rudragouda R	A J institute of dental sciences	Dept of Oral and Maxillofacial surgery A J Institute of dental sciences Kuntikana Mangalore Dakshina Kannada KARNATAKA	9880244358 rudragoudar05@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AJIDS Ethics committe	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical, (2) ICD-10 Condition: K099\|\|Cyst of oral region, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	demineralized freezed dried bone allograt	demineralized freezed dried bone allograt alone is used as a graft material once at the procedure and then followed up to three months
Intervention	demineralized freezed dried bone allograt combined with platelet rich fibrin	demineralized freezed dried bone allograt is combined with prf as a adjuvant is mixed together and used as a graft material once during the procedure and followed upto three months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1. Patients of either sex aged between 18 and 45 years. 2. Patients belonging to ASA 1 and 2. 3. Patients with cystic defect measuring above 5mms to 50 mms.

ExclusionCriteria

Details

1. Pregnant or lactating women.
2. Patients diagnosed with systemic bone disorders
3. Patients under bisphosphonate therapy
4. Patients previously undergone radiotherapy
5. Patients contraindicated for graft placement.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

On-site computer system

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
bone density evaluation	baseline and 3 months

Secondary Outcome

Outcome	TimePoints
Evaluate the efficacy of DFDBA in the management of Oral and Maxillofacial cystic defects	baseline
Evaluate the efficacy of DFDBA combined with PRF in the management of Oral and Maxillofacial cystic defects	baseline
Compare the effectiveness of DFDBA combined with PRF and DFDBA when used alone in Oral and Maxillofacial cystic defects to assess the bone volume restoration and overall defect resolution	baseline

Target Sample Size

Total Sample Size="18"
Sample Size from India="18"
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 2

Date of First Enrollment (India)

05/05/2024

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)

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 is a interventional prospective study including 18 patients which are devided into 2 groups of 9 patients each, group 1 will be DFDBA bone graft alone and group 2 will be DFDBA graft combined with PRF as an adjuvant.

this study aims to evaluate The effectiveness of demineralized freezed dried bone allograft alone versus when combined with platelet rich fibrin in the management of cystic defects in oral and maxillofacial region.