| CTRI Number |
CTRI/2012/07/002793 [Registered on: 12/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
29/06/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare the effect of a synthetic bone graft material alone and in combination with a component of blood (platelet membrane) in bony defects associated with gum diseases |
|
Scientific Title of Study
|
A clinical evaluation of efficacy of bone graft material (Beta -tricalcium phosphate + hydroxyapatite) alone and in combination with platelet rich fibrin membrane in treatment of periodontal intrabony defects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja S Malpani |
| Designation |
Post Graduate Student (Periodontology and Oral Implantology) |
| Affiliation |
S M B T Dental College, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi, Sangamner,
Ahmadnagar
MAHARASHTRA
422 608
India |
| Phone |
9960746376 |
| Fax |
|
| Email |
poojame2050@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Om N Baghele |
| Designation |
MDS, MBA –Professor and Guide |
| Affiliation |
S M B T Dental College and Hospital, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College, Sangamner,
Ahmadnagar
MAHARASHTRA
422 608
India |
| Phone |
9321019946 |
| Fax |
02425-222867 |
| Email |
drom94@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja S Malpani |
| Designation |
Post Graduate Student (Periodontology and Oral Implantology) |
| Affiliation |
S M B T Dental College, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi, Sangamner,
Ahmadnagar
MAHARASHTRA
422 608
India |
| Phone |
9960746376 |
| Fax |
|
| Email |
poojame2050@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SMBT DENTAL COLLEGE HOSPITAL |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi, Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
|
| 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 |
| Pooja S Malpani |
Department of Periodontology and Oral Implantology, S M B T Dental College, |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi, Sangamner.
Ahmadnagar
MAHARASHTRA |
9960746376
poojame2050@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra University of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Periodontitis (osseous defects), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Patients in control group with intrabony defects will be treated with bone graft material ( Beta - tricalcium phosphate + hydroxyapatite) alone |
| Intervention |
Group B |
Patients in test group with intrabony defects will be treated with bone graft material (Beta - tricalcium phosphate + hydroxyapatite) in combination with Platelet Rich Fibrin membrane |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Intrabony defects in maxillary and mandibular arch
2. Patients with two or more intrabony defects (Isolateral/contralateral) as well as isolated intrabony defects
3. Intrabony defects (IBD)greater than or equal to 3 mm deep [distance between alveolar crest and base of the defect on intraoral periapical radiograph (IOPA)] along with an interproximal probing depth (PD) greater than or equal to 5 mm following phase I therapy
4. Absence of overt clinical inflammation at the time of surgery
5. Adequate amounts of interdental soft tissues
6. Absence of any local anatomical limitations
7. Patient willing for surgery and ready to give written consent
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic illness known to affect the outcomes of periodontal therapy, such as diabetes mellitus, cardiac diseases, platelet count less than 200,000/mm cube, or immunocompromised (e.g., HIV individuals) patients taking medications, such as corticosteroids.
2.Individuals allergic to medications
3.Pregnant or lactating women
4.Patients using tobacco in any form
5.Individuals with unacceptable oral hygiene (plaque index [PI] greater than 1.5).
|
|
|
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 |
| Probing depth, Clinical attachment level |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic evaluation with the help of image analysis software |
4 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
17/01/2012 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The periodontal infection results from the subgingival colonization of periodontopathic bacteria. However, subgingival infection can cause anatomic changes in periodontal tissues (i.e., increased probing depth [PD] and intrabony defects) that can produce local conditions that favor recurrence of the disease. Periodontal treatment includes the surgical elimination of anatomic deformities by restoring the lost supporting tissues. Periodontal regeneration refers to the reproduction or reconstitution of a lost or injured part. Osseous grafting and guided tissue regeneration (GTR) are the two techniques with the most histologic documentation of periodontal regeneration in intrabony defect. Various growth factors have been shown to accelerate the healing process. Platelet also releases growth factors which are natural biological mediators that regulate crucial cellular events involved in tissue repair. So platelet rich fibrin will provide growth factors and additionally the simplicity of procedure will help in treatment of intrabony defects. The aim of the study is to evaluate the efficacy of the bone graft material (Beta-tricalcium phosphate + hydroxyapatite) alone and in combination with Platelet Rich Fibrin membrane in treatment of intrabony defects.
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