| CTRI Number |
CTRI/2025/10/096217 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on how biting and chewing times change when using a fixed teeth ,after making the bite digitally using digital techniques. |
|
Scientific Title of Study
|
Tek-scan analysis of changes in occlusion time and disclusion time on fixed partial denture involving distal terminal abutment fabricated after after digital bite scan with and without relined putty index- a clinical 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 Rishi Shaik |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Pg clinic no.- 8, Department of Prosthodontics, First floor, Block 2, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9398591515 |
| Fax |
|
| Email |
rishi.shaik@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Bheemalingeswara Rao |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Pg clinic no.- 8, Department of Prosthodontics, First floor, Block 2, Vishnu Dental College, Vishnupur, 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 Bheemalingeswara Rao |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Pg clinic no.- 8, Department of Prosthodontics, First floor, Block 2, Vishnu Dental College, Vishnupur, 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,Vishnupur,Bhimavaram,West Godavari,534202,Andhra Pradesh,India. |
|
|
Primary Sponsor
|
| Name |
DrRishi Shaik |
| Address |
Pg Clinic 8,Block 2,Vishnu Dental College,Vishnupur,Bhimavaram,534202. |
| 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 Rishi Shaik |
Vishnu Dental College |
Pg clinic no.:8, Department of Prosthodontics, First Floor, Block 2, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH |
9398591515
rishi.shaik@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: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pre operative baseline tek scan occlusion and disclusion values. |
Tek scan analysis of occlusion time and disclusion time of edentulous condition. |
| Intervention |
Relined putty index. |
Tek scan analysis of occlusion time and disclusion times after fixed partial denture rehabilitation with and without relined putty index. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 years and above.
Unilateral Mandibular or Maxillary Posterior edentulous space with no tooth distal to posterior abutment.
Intact opposing arch
Healthy Periodontal condition.
Patients with acceptable range of OT is less than or equal to 0.2 seconds and DT is less than or equa to 0.4 seconds will be included.
|
|
| ExclusionCriteria |
| Details |
Rotated and tilted abutment teeth.
Skeletal class II or class III molar relation.
Presence of symptomatic temporomandibular disorders.
Presence of Orofacial Myalgia.
Patients lacking Neuromuscular control.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Occlusion time and Disclusion time. |
Baseline, Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
28/10/2025 |
| 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="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
|
a) Patients visiting the Department of Prosthodontics and implantology for fixed denture prosthesis with unilateral maxillary or mandibular posterior edentulous area having remaining teeth intact fulfilling the inclusion criteria and willing to cooperate for the study. Patients are selected from both the sexes of age 20years and above. A sample of 16 patients will be included in the study. Pre-operation occlusion time OT and disclusion time DT will be recorded using Tek-Scan tek-scan-0. After the fabrication of FPD with inter occlusal record made using intra oral scanner along with the relined index, OT and DT will be recorded using Tek-Scan tek-scan-1.After the fabrication of FPD with inter occlusal record made using only intraoral scanner without relined putty index, OT and DT will be recorded using Tek-Scan tek-scan-2.Comparision of OT and DT between tek scan-0 and tek scan -1 and tek scan-2. |