| CTRI Number |
CTRI/2020/01/022753 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
24/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of bone resorption after tooth extraction by using bone substitutes |
|
Scientific Title of Study
|
A comparative study on alveolar ridge preservation with β-TCP in combination with Hemocollagen and Hemocollagen alone-A randomized control 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 Asma Ahmed |
| Designation |
Post graduate student |
| Affiliation |
Rishiraj College of Dental Sciences and Research Centre |
| Address |
Department Of Periodontology
first floor, room no 202
Rishiraj College of Dental Sciences and Research Centre,
Gandhi nagar , Near airport
Bhopal
Bhopal
MADHYA PRADESH
462036
India |
| Phone |
9827762862 |
| Fax |
|
| Email |
asmikhan2205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Agrawal |
| Designation |
Professor and Guide |
| Affiliation |
Department of Periodontology, Rishiraj College of Dental Sciences and Research Centre |
| Address |
Department of Periodontology
Frst floor, room no 202
Rishiraj College of Dental Sciences and Research Centre,
Gandhi nagar , Near airport
Bhopal
Bhopal
MADHYA PRADESH
462036
India |
| Phone |
9424619777 |
| Fax |
|
| Email |
dna7kgmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asma Ahmed |
| Designation |
Post graduate student |
| Affiliation |
Rishiraj College of Dental Sciences and Research Centre, |
| Address |
Department of Periodontology
First floor, room no 202
Rishiraj College of Dental sciences and Research Centre,
Gandhi nagar , Near airport
Bhopal
Bhopal
MADHYA PRADESH
462036
India |
| Phone |
9827762862 |
| Fax |
|
| Email |
asmikhan2205@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishiraj College of Dental Sciences and Research Centre,
Gandhi nagar near airport,
Bhopal 462036 |
|
|
Primary Sponsor
|
| Name |
Rishiraj College of Dental Science and Research Centre |
| Address |
Rishiraj College of Dental Science and Research Centre
Gandhi Nagar, Near Airport, Bhopal
Madhya Pradesh 462036
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Jaju |
Diya Dental Imaging Centre |
A 67 Near Shekhar Hospital, Shahapura.
Bhopal
MADHYA PRADESH |
9752093011
diyadentalimaging@gmail.com |
| Dr Asma Ahmed |
Rishiraj College of Dental Science and Research centre |
Department Of Periodontology
First floor, room no 202
Bhopal
MADHYA PRADESH |
9827762862
asmikhan2205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethical Committee formed by MPMSU and RCDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects chosen will be the ones who have been advised extraction of teeth because of dental caries or trauma.They will otherwise not have any positive medical history. |
| Patients |
(1) ICD-10 Condition: R948||Abnormal results of function studies of other organs and systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alveolar ridge preservation with Beta TCP in combination with hemocollagen |
After Atraumatic tooth extraction, the socket is immediately inserted with Beta TCP and hemocollagen .This is done just once and the result can be measured after 8 weeks. |
| Comparator Agent |
Alveolar ridge preservation with hemocollagen alone. |
After Atraumatic tooth extraction, the socket is immediately inserted with hemocollagen bone grafting material alone .This is done just once and the result for this can be measured after 8 weeks. |
| Comparator Agent |
control |
No bone grafting material added in the socket after atraumatic tooth extraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients indicated for extraction because of caries and trauma.
2) Mandibular single rooted tooth or teeth.
3) No history of tobacco abuse in any form.
4) No alcohol or drug abuse. |
|
| ExclusionCriteria |
| Details |
1) Alveolar bone fracture due to extraction or any other reasons.
2) Pregnancy.
3) known history with diabetes mellitus, osteoporosis and blood dyscrasis.
4) Known allergy to foreign material or Local anaesthetics.
5) Patients who had undergone Chemotherapy or Radiotherapy.
6) Traumatic extractions.
7) Patients on Bisphosphonates drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effective alveolar ridge preservation with bone grafting materials used in combination and alone. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adequate bone will be preserved for prosthesis or replacement of the missing tooth in future in both the groups. |
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomised, single blinded, parallel group, control, clinical trial comparing the effectiveness of bone grafting materials for socket preservation.Subjects who are advised extraction due to trauma or dental caries will be broadly grouped into three . After doing atraumatic extraction under local anaesthesia, in group 1: Beta -TCP in combination with HC and ,in group 2: HC alone will be inserted with light pressure and stabilised by suturing.The patients will then be directed to the CBCT centre for bone analysis and this will form the baseline readings.It will record the alveolar bone width and height both buccally and lingually.The patient will then be recalled after 8weeks and another CBCT scan will be done for the same site.There will be a control group , in which no bone grafting will be added. It has been hypothesized that there will be effective bone formation observed after 8weeks in sockets with bone grafting materials and there will be minimal difference between the two materials inserted. This ridge preservation will help in giving prosthesis like implants, thus restoring the architecture ,occlusion, function and esthetics. |