| CTRI Number |
CTRI/2025/10/096698 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Occlusal Force Changes in Mandibular Implant Crowns Over Time Using T-Scan III |
|
Scientific Title of Study
|
Comparative evaluation of occlusal force changes in mandibular premolar and molar implant-supported crown at 3 month and 6 month interval, using T-scan III: An in-vivo study. |
| 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 Rajeshwari Yadav |
| Designation |
Post graduate student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9075811262 |
| Fax |
|
| Email |
rajeshwariy54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaykumar Gade |
| Designation |
Professor and PG guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9921425443 |
| Fax |
|
| Email |
jaykumar.gade@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaykumar Gade |
| Designation |
Professor and PG guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9921425443 |
| Fax |
|
| Email |
jaykumar.gade@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics Crown and Bridge, Swargiya Dadasaheb Kalmegh Smruti dental college and hospital, Sangam road, Wanadongari, Hingna, Nagpur |
|
|
Primary Sponsor
|
| Name |
Rajeshwari Dilipkumar Yadav |
| Address |
Swargiya Dadasaheb Kalmegh Smruti dental college and hospital, Sangam road, Wanadongari, Hingna, Nagpur |
| 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 Rajeshwari Dilipkumar Yadav |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA |
9075811262
rajeshwariy54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee- Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital ,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients irrespective of gender will be selected.
2)Patients in age group 18-60 years will be selected.
3)Patients indicated for delayed implant supported crown in left/right side first or second premolar and/or first or second molar with both mesial and distal teeth present will be selected.
4)Patient having opposing natural tooth present.
5)Patients whose crown will be fabricated using Implant Protective occlusion concept.
6)Patients with no bruxism and not undergoing any orthodontic treatment will be selected.
7)Volunteer patients who agree to give informed consent will be considered as individuals for the research.
|
|
| ExclusionCriteria |
| Details |
1)Patients who presented with Temporomandibular Joint disorders.
2)Patients with history of any parafunctional habits.
3)Patients with muscle abnormality including dystrophy or hypertrophy.
4)Patients whose crown are not fabricated using Implant Protected occlusion concept.
5)Patients who had undergone occlusion adjustment.
6)Patients who are receiving orthodontic treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is statistically significant change in occlusal forces on mandibular premolar and molar implant supported crown at 3 month and 6 month interval, using T scan III |
Immediately after implant placement, 3 month and 6 month after implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no statistically significant change in occlusal forces on mandibular premolar & molar implant supported crown at 3 month & 6 month interval, using T scan III |
3 month & 6 month after 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)
|
21/11/2025 |
| 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="2" |
|
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
|
Dental implants exhibit low proprioceptive feedback and low tactile sensitivity due to the absence of periodontal mechanoreceptors. Therefore, due to the weaker protective mechanism in dental implants, it seems that the occlusion concepts for implant-supported prostheses must be modified. Objectives of implant occlusion are to minimize overload on bone implant interface and implant prosthesis to maintain implant load within physiologic limits of individual occlusion and finally to provide long term stability to implant and implant prosthesis. Because of the light occlusion after the implant prostheses delivery the natural dentition opposing implant crown continues to erupt so that contact with the implant-supported prosthesis will be established. This may play an important role in the subsequent changes in occlusal force distribution and Occlusion Time. The T-Scan III system can accurately identify occlusal force distribution and the sequence of occlusal time in natural teeth and implant prostheses. The purpose of this clinical study was to describe and analyse the longitudinal variation of occlusal contact, including changes in occlusion time and disocclusion time in single posterior fixed implant supported prostheses by using the T-Scan III system. The rational or need of the study is to analyse changes in occlusion time and disocclusion time in single posterior partial fixed implant supported prostheses over time. The analysis will be done before placement of implant supported crown, immediately after placement and at an interval of 3 and 6 months in partially edentulous patients. PRIMARY OBJECTIVE: 1)To evaluate and compare occlusal force changes in Premolar implant supported crown at 3 and 6 months interval using T-scan III. 2)To evaluate and compare occlusal force changes in Molar implant supported crown at 3 and 6 months interval using T-scan III 3) To quantify the occlusal force changes of Premolar and Molar implant supported crown at 3 and 6 months interval using T-scan III METHOD OF MEASUREMENT: A complete case history of the patient will be taken, 20 patients in age group 18-60 years will be evaluated. Each patient will be explained in detail about the procedure in the local vernacular language (Marathi, Hindi or English). They will be informed about their right to refuse and will be then asked to sign the consent form. After 3 months of first stage implant placement surgery, healing abutment will be placed and impression will be taken after 10-15 days. Metal fused with ceramic crowns will be fabricated. After 3 months of first stage implant placement surgery, healing abutment will be placed and impression will be taken after 10-15 days. Metal fused with ceramic crowns will be fabricated. Try in and T-scan evaluation will be done. The occlusal force on distal tooth is checked immediately after crown placement and it is ensured that it remains constant on subsequent scanning for reference or standardizing purpose. Changes in occlusal force on premolar implant-supported crown (Group A) and Molar implant- supported crown (Group B) will be evaluated at 3 and 6 month time interval. The study protocol design will be approved by the Institutional Ethics Committee. Changes in occlusal force on premolar implant-supported crown (Group A) and Molar implant- supported crown (Group B) will be evaluated at 3 and 6 month time interval. The study protocol design will be approved by the Institutional Ethics Committee |