| CTRI Number |
CTRI/2023/07/055423 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of the placement of tooth implant using three different techniques and patient experience.
|
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Scientific Title of Study
|
Computer Aided versus Conventional implant placement in assessing Precision, Predictability and Patient reported outcome measures-A Randomized Controlled 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 |
Veeramallu Nageswari |
| Designation |
postgraduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2,Room no-7,
Department of Periodontics and Implantology, Vishnu Dental college, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
6300558030 |
| Fax |
|
| Email |
veeramallunageswari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2,Room no-7,Department of Periodontics and Implantology, Vishnu Dental college, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2,Room no-7,Department of Periodontics and Implantology, Vishnu Dental college, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram,
West Godavari district,Andhra Pradesh,534202. |
|
|
Primary Sponsor
|
| Name |
Veeramallu Nageswari |
| Address |
Block 2,Room no-7,Department of Periodontics and Implantology, Vishnu Dental college, Vishnupur, Bhimavaram. |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Veeramallu Nageswari |
Vishnu Dental College |
Block 2,Room no-7,Department of Periodontics and Implantology, Vishnu Dental college, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH |
6300558030
veeramallunageswari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method. |
Implants will be placed in edentulous mandibular posteriors using conventional (free hand method). Accuracy check will be assessed using Evalunav module in navident software.Implant stability, crestal bone loss and patient reported outcome measures will also be measured.Time duration required for placement is 50 min to 60 min. |
| Intervention |
Dynamic Navigation system . |
Implants will be placed in edentulous mandibular posterior areas using Dynamic navigation system(Navident). Accuracy check will be assessed using Evalunav module in navident software. lmplant stability, crestal bone loss and patient reported outcome measures will also be measured.Time duration required for placement is 45 min to 60 mmin. |
| Intervention |
Static guided method |
Implants will be placed in edentulous mandibular posterior areas using static guide. Accuracy check will be assessed using Implant studio software.Implant stability, crestal bone loss and patient reported outcome measures will also be measured.Time duration required for placement is 40 min to 50 min. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age range of 20-60 years
2. Partially edentulous mandibular premolars and molars
3.Adequate bone depth and width for implant placement
4.Anatomically suitable for all three protocols
(a) Freehand implant placement
(b) Static CAIS
(c) Dynamic CAIS
5.ASA 1 and 2 classification patients
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled systemic diseases
2. Pregnancy or lactating women
3. Chronic smokers
4. Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C )
5. Known allergy to any component of the implant or implant guide
6. Patients undergoing radiation therapy
7. Patients under bisphosphonate therapy
8.Patients under antibiotic therapy
9. INR >2.5s
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Entry (2d) deviation
2. Apical (3d) deviation
3. Apex (v) deviation
4. Angular deviation
5. Pre-operative patient’s expectations from dental implant surgery.
6. Post-operative healing & experience questionnaire after dental implant surgery
|
1. Entry (2d) deviation at baseline, immediately after implant placement
2. Apical (3d) deviation at baseline, immediately after implant placement
3. Apex (v) deviation at baseline, immediately after implant placement
4. Angular deviation at baseline, immediately after implant placement
5. Pre-operative patient’s expectations from dental implant surgery at baseline
6. Post-operative healing & experience questionnaire after dental implant surgery at 6hrs, 1st, 2nd, 3rd, 5th and 7th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographical parameters
1.Crestal bone loss
Clinical parameters
2.Implant stability
|
crestal bone loss at baseline, 3 & 6 months & implant stability at 3 months |
|
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Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/07/2023 |
| 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="2"
Months="0"
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
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Brief Summary
|
The aim of the study is to evaluate and compare the precision and patient reported outcome measures of conventional, static guided and dynamic navigation implants. A total of 45 patients with partially edentulous mandibular posteriors will be selected from out patient department of periodontics and implantology, Vishnu Dental college, Bhimavaram and will be randomly assigned in to three groups by using computerized generated code. Entry (2d) deviation, Apical (3d) deviation, Apex(V) deviation, angular deviation, crestal bone loss, implant stability will be assessed and patient reported outcome measures will be assessed by using questionnaire form, which includes • Pre-operative patient’s expectations from dental implant surgery. • Post-operative healing questionnaire • Post-operative patients experience with dental implant surgery • Patient’s acceptance of post -operative healing events and overall satisfaction with dental implant surgery will be measured . Crestal bone loss at baseline,3 and 6 months and implant stability at 3 months will also be measured.
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