| CTRI Number |
CTRI/2024/09/073272 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of force distribution on the supporting teeth in the fixed bridge of patients with few missing natural teeth using a video recording technique |
|
Scientific Title of Study
|
Tek-scan analysis of occlusal contacts and force distribution on fixed partial denture involving distal terminal abutment fabricated after bite registration using two inter occlusal record techniques.
|
| 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 Vinukonda venkata sai divya sree |
| Designation |
Mds Student |
| Affiliation |
Vishnu Dental College |
| Address |
pg-8
Department Of prosthodontics And Crown And Bridge
Block 2
Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8179762824 |
| Fax |
|
| Email |
v.saidivyasree36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Bheemalingeswra rao |
| Designation |
Professor And Head Of The Department Of Prosthodontics |
| Affiliation |
Vishnu Dental College |
| Address |
Pg-8
Department Of Prosthodontics And Crown And Bridge
Block 2
Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701008765 |
| Fax |
|
| Email |
bheemalingeswararao.d@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Bheemalingeswra rao |
| Designation |
Professor And Head Of The Department Of Prosthodontics |
| Affiliation |
Vishnu Dental College |
| Address |
Pg-8
Department Of Prosthodontics And Crown And Bridge
Block 2
Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9701008765 |
| Fax |
|
| Email |
bheemalingeswararao.d@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Vishnupuram,Bhimavaram,
534202
West Godavari District, Andhra Pradesh,India
|
|
|
Primary Sponsor
|
| Name |
Dr Vinukonda Venkata Sai Divya Sree |
| Address |
Pg clinic 8, Block 2,
Department of Prosthodontic and Crown and Bridge,
Vishnu Dental College,
Bhimavaram - 534202, West Godavari District, Andhra Pradesh, India |
| 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 D Bheemalingeswara Rao |
VISHNU DENTAL COLLEGE |
Department Of Prosthodontics And Crown And Bridge
Block 2
Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH |
9701008765
-
bheemalingeswararao.d@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Vishnu Dental College |
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 |
Post operative tek scan with fixed partial denture fabricated using intra oral scan only |
After recording preoperative tek-scan and intra oral scan, tooth preparation of abutment teeth will be done followed by post operative intra oral scan. Temporary fixed partial dentures will be fabricated using intra oral scan records and cemented in patients, post operative tek-scan record will be made with time interval of 30 minutes |
| Intervention |
Post operative tek scan with fixed partial denture fabricated using intra oral scan with bite registration |
After recording preoperative tek-scan and intra oral scan, a preoperative putty index of tooth will be made followed by tooth preparation of abutment teeth. post operative intra oral scan will be performed using relined bite then temporary fixed partial dentures will be fabricated using intra oral scan records and cemented in patients, post operative tek-scan record will be made with time interval of 30 minutes
|
| Comparator Agent |
Preoperative TEK scan and Intra oral scan |
Pre operative tek scan and intra oral scan will be recorded prior to the tooth preparation for a total duration of 8min |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20 years and above.
2. Unilateral tooth bound Mandibular or Maxillary Posterior edentulous space.
3. Remaining teeth in the oral cavity should be intact with or without restorations.
4. Healthy Periodontal condition.
5. Supra erupted opposing teeth will be reduced and restored with crown and
considered. |
|
| ExclusionCriteria |
| Details |
1) Presence of any rotated and tilted abutment teeth.
2) Patients having periodontitis.
3) Patients with class II or class III molar relation.
GENERALIZED
5) Presence of symptomatic temporomandibular disorders.
6) Presence of Orofacial Myalgia.
7) Patients lacking Neuromuscular control.
8) Patients undergoing any Orthodontic or Periodontic
treatments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Force distribution and transfer of occlusal contacts will be analyzed using tek scan |
30 min post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
14/09/2024 |
| 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="0"
Months="6"
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
|
Subjects fulfilling the inclusion criteria will be explained about the nature of the study and informed consent will be obtained. Pre-operative putty index will be made, Pre-operative intra oral scan, Tek scan will be done . Conventional tooth preparation of abutments will be done. Inter occlusal record-1 is made by relining the pre operative putty index with bite registration paste at abutments. Inter occlusal record-1 will be used in post operative intra oral scannig. Inter occlusal record-2 is made using intra oral scanner without using relining technique.Two fixed partial dentures will be fabricated using two post operative intraoral scan records . Tek scan with two cemented fixed partial dentures will be recorded .The occlusal contacts and force distribution in pre and post operative tek-scan records will be compared. The data will be subjected to statistical analysis. |