| CTRI Number |
CTRI/2024/05/066806 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| 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 trial to compare and evaluate the stability of dental implants placed using two techniques, conventional drill and magnetic mallet. |
|
Scientific Title of Study
|
Comparative evaluation of stability of dental implants placed using conventional drill versus magnetic mallet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yangchan Dolma |
| Designation |
Post-graduate student |
| Affiliation |
Maulana Azad Institute Of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg,
New Delhi
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9871597872 |
| Fax |
|
| Email |
yangchandolma143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundeep Kaur Lamba |
| Designation |
Professor And Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg,
New Delhi
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9654700980 |
| Fax |
|
| Email |
arundeep.kaur.lamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yangchan Dolma |
| Designation |
Post-grauate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg,
New Delhi
Bahadur Shah Zafar Marg,
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9871597872 |
| Fax |
|
| Email |
yangchandolma143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Oral Implantology,
Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg,
New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Yangchan Dolma |
| Address |
Department of Periodontics and Oral Implantology,
Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg,
New Delhi-110002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Yangchan Dolma |
Maulana Azad Institute of Dental Sciences |
Room no 601, 6th floor, Department of Periodontics and Oral Implantology
Central
DELHI |
9871597872
yangchandolma143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute Of Dental Sciences, New Delhi ( Govt. of NCT of Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drill technique |
Dental implants will be placed using conventional drill technique.
Duration of intervention- 24 months |
| Intervention |
Magnetic mallet technique |
Dental implants will be placed using magnetic malleting technique.
Duration of intervention- 24 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex between the age group of 20 to 55 years who sign the informed consent for the study.
2. Presence of single or multiple edentulous areas in maxilla and/or mandible.
3. Subjects who want dental implant and have sufficient available bone for implant placement.
4. Subjects having sound general health.
5. Absence of any signs of pathology at surgical site.
6. Non-smokers
|
|
| ExclusionCriteria |
| Details |
1. Presence of poor oral hygiene.
2. Uncontrolled systemic diseases (e.g., uncontrolled diabetes, uncontrolled hypertension, bleeding disorders), on immunosuppressive or anti-coagulation medications.
3. Presence of acute or chronic sinus problems.
4. Presence of bone disease (Paget disease, rickets, osteoporosis, arthritis, multiple myeloma etc.). And radiographic evidence of bone tumor (benign/malignant) or cyst.
5. Subjects under long-term bisphosphonate therapy.
6. Pregnant women and/or expected pregnancy during the study period.
7. Lactating women.
8. Alcohol or drug abuse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability |
immediately after dental implant placement and
at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient centered outcome- discomfort experienced during the surgical procedure. |
on the day of dental implant placement |
|
|
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)
|
13/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a randomised, single blinded, parallel group, control trial comparing the stability of dental implants placed using conventional drill versus magnetic mallet in subjects having single or multiple edentulous areas in maxilla and/or mandible that will be conducted in Department of Periodontics and Oral Implantology, Maulana Azad Institute Of Dental Sciences, New Delhi in India. The primary outcome measure will be stability of dental implants, immediately after implant placement and at 6 months. The secondary outcome will be patient-centred outcome: discomfort experienced during the surgical procedure. |