| CTRI Number |
CTRI/2025/11/098094 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess and compare immediate and delayed crown placement on implants for missing lower back tooth. |
|
Scientific Title of Study
|
A comparative evaluation of immediate loading versus delayed loading of single missing mandibular molars in healed sites using wide bodied implants. A randomized controlled clinical trial. |
| 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 Manasa U |
| Designation |
Post graduate student |
| Affiliation |
Vokkaligara Sangha Dental College and Hospital |
| Address |
Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra road, next to KIMS hospital, Parvathipuram, Visvesvarapuram, Basavangudi, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560004
India |
| Phone |
08197533221 |
| Fax |
|
| Email |
dr.manasagowda06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayak S Gowda |
| Designation |
Professor and Head of Department |
| Affiliation |
Vokkaligara Sangha Dental College and Hospital |
| Address |
Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra road, next to KIMS hospital, Parvathipuram, Visvesvarapuram, Basavangudi, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560004
India |
| Phone |
9008151409 |
| Fax |
|
| Email |
umeshakenchaiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinayak S Gowda |
| Designation |
Professor and Head of Department |
| Affiliation |
Vokkaligara Sangha Dental College and Hospital |
| Address |
Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra road, next to KIMS hospital, Parvathipuram, Visvesvarapuram, Basavangudi, Bengaluru, Karnataka.
Bangalore
KARNATAKA
560004
India |
| Phone |
9008151409 |
| Fax |
|
| Email |
umeshakenchaiah@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manasa U |
| Address |
Department of periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra road, next to KIMS hospital, Parvathipuram, Visvesvarapuram, Basavangudi, Bengaluru, Karnataka. |
| Type of Sponsor |
Other [Private Dental 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 |
| Manasa U |
Vokkaligara Sangha Dental College and Hospital |
Room number-5, Department of Periodontics, Vokkaligara Sangha Dental College and Hospital, Krishna Rajendra road, next to KIMS hospital, Parvathipuram, Visvesvarapuram, Basavangudi, Bengaluru, Karnataka.
Bangalore
KARNATAKA |
8197533221
dr.manasagowda06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with missing mandibular molars. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IMPLANT PLACEMENET IN THE MISSING MANDIBULAR MOLAR TOOTH REGION WITH DELAYED LOADING OF THE IMPLANTS. |
The control group will be treated with implant placement in the missing mandibular molar tooth. For the implant placement all implant drills recommended by the manufacturer will be used depending upon the availability of bone and its quality to achieve adequate primary stability with necessary modifications including under sizing the osteotomy. The peak insertion torque will be measured during the seating of the most coronal 4 to 5 implant threads by means of the same physio dispenser unit with a torque measuring option which was used to place the implant and recorded as being 30, 40, or 50 Newton centimetre and given a healing period of three months. Three months after the implants were placed, a final impression was made and permanent porcelain-fused-to-metal, cemented retained restorations with occlusal access hole were inserted. The cemented restorations were made on abutments provided by the implant manufacturer . The crown margin was positioned 0.5 to 1 millimetre into the peri-implant sulcus.
It is a two session intervention and total duration of intervention will be 6 months for each patient.
|
| Intervention |
IMPLANT PLACEMENET IN THE MISSING MANDIBULAR MOLAR TOOTH REGION WITH IMMEDIATE FUNCTIONAL LOADING OF THE IMPLANTS. |
The test sites will be treated with implant placement in the missing mandibular molar tooth. For the implant placement all implant drills recommended by the manufacturer will be used depending upon the availability of bone and its quality to achieve adequate primary stability with necessary modifications including under sizing the osteotomy. The peak insertion torque will be measured during the seating of the most coronal 4 to 5 implant threads by means of the same physio dispenser unit with a torque measuring option which was used to place the implant and recorded as being 30, 40, or 50 Newton centimetre. Provisional cemented retained restorations with occlusal access hole will be connected to the immediately loaded implants within 24 hours of implant placement. Three months after the implants were placed, a final impression was made and permanent porcelain-fused-to-metal, cemented retained restorations with occlusal access hole were inserted. The cemented restorations were made on abutments provided by the implant manufacturer . The crown margin was positioned 0.5 to 1 millimetre into the peri-implant sulcus. It is a two session intervention and total duration of intervention will be 6 months for each patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group: 18 - 65years.
2.Healed Single Edentulous first molar site in the mandible with sufficient bone so as to obtain sufficient implant primary stability.
3.Patients with D2 bone quality in the posterior mandible as assessed by CBCT.
4.Opposing occlusion with the natural dentition or fixed restorations.
5.No need for bone augmentation.
6.Medically fit patients for surgery under local anaesthesia.
7.Patients who will strictly follow and maintain proper oral hygiene to prevent peri-implantitis.
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients.
2.Chronic smokers.
3.Patients with Para-functional habits.
4.Poor bone quality or volume.
5.Non-compliant patients.
6.Patients with uncontrolled diabetes with HbA1c greater than 7.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative parameters
•To record the crestal bone level at baseline , 3 months and at 6 months in both test and control groups using cone beam computed tomography scan. The first bone-implant contact at surgery was defined as the baseline level.
•To compare the implant success rates between the test and control group, if any. Implant failure criteria:
1. Absence of complete extrusion of the implant.
2. Implant should remain clinically immobile on manual testing.
Implants not fulfilling both of the above mentioned criteria are considered as failed implants.
|
Baseline, 3 months, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/12/2025 |
| 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="1"
Months="3"
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 is a randomized controlled clinical study evaluating the clinical
and radiographic outcomes of immediate loading versus delayed loading of wide-bodied
implants placed in single missing mandibular molar healed sites. Twenty four patients will receive implant placement in the mandibular missing molar tooth region among which the twelve patients in the test group will be rehabilitated with immediate functional loading of the implants and twelve group in the control group will be rehabilitated with a final prosthesis after 3 months of healing period. Post operative parameters will be to assess and compare the crestal bone level at baseline, 3 months and 6 months and to compare the implant success rates between the two groups at the end of 6 months in terms of clinical mobility of the implant and complete extrusion of the implant. |