| CTRI Number |
CTRI/2025/07/090814 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Drilling the mandibular molar before extraction for placement of dental implants |
|
Scientific Title of Study
|
Implant placement by interradicular bone drilling before mandibular molar extraction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RamkarthikS |
| Designation |
Post Graduate student |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
8072131946 |
| Fax |
|
| Email |
surgeryramkarthik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Vikraman |
| Designation |
Head of the department and Guide |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
9840059597 |
| Fax |
|
| Email |
vikramanvikraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RamkarthikS |
| Designation |
Post Graduate student |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119
Chennai
TAMIL NADU
600119
India |
| Phone |
8072131946 |
| Fax |
|
| Email |
surgeryramkarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAGAS DENTAL COLLEGE AND HOSPITALdepartment of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119 |
|
|
Primary Sponsor
|
| Name |
Ramkarthik S |
| Address |
department of oral and maxillofacial surgery, room number2, ragas dental college
2/102 East Coast Road Uthandi chennai 600119 |
| 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 Ramkarthik S |
RAGAS DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NUMBER 2 RAGAS DENTAL COLLEGE AND HOSPITAL 2/102 East Coast Road Uthandi chennai 600119
Chennai
TAMIL NADU |
08072131946
surgeryramkarthik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
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 |
| Intervention |
Dental Implant |
Implants will be placed at the height of cervicoenamel junction of adjacent teeth and at the center of socket to observe the preservation of marginal bone. the implant will be observed for 6 months to evaluate proximal marginal bone loss between prosthetic crown and natural teeth |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All patients who desire implant based rehabilitation of grossly destructed mandibular first molar teeth
Age group above 18 years and below 45 years
Both sexes would be included
Good general health and oral health
Be available for follow up examination
No history of diagnosed bone disease or medication known to affect bone metabolism
Patient with fair periodontal status.
|
|
| ExclusionCriteria |
| Details |
Compromised health condition which would contraindicate surgical treatment
Compromised periodontal status
Any allergies related to the procedure to be done
Pregnancy or lactation
Any history of psychiatric disorder
Not willing to sign informed consent
Any infections at the area of intertest
Patients with parafunctional habits such as bruxism and clenching
History of systemic diseases that would contraindicate the surgical treatment
Tooth with fused roots with no bifurcation and constricted bifurcation
Periapical pathology in relation to the tooth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| preservation of marginal bone on mesial and distal sides of prosthesis provided |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| center placement of implant in interradicular area |
immediately |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 4 |
|
Date of First Enrollment (India)
|
07/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 prospective study wherein dental implants are placed using he initial drill which is drilled between the roots which acts as natural guide for placement of dental implants. The implants are placed at the height of cervicoenamel junction of adjacent teeth which prevents marginal bone loss between the prosthetic crown and the adjacent teeth which futhther prevents food lodgment as this food lodgment will lead to periimplantitis. |