| CTRI Number |
CTRI/2024/09/073313 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative evaluation of new implant placement technique by conventional way and computerized method: A randomized clinical trial |
|
Scientific Title of Study
|
A comparative evaluation of immediate implant placement by Vestibular socket therapy between Dynamic navigation system and conventional placement in defective labial wall cases: A Randomized 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 |
Mohamed Thaha A |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Institute of Medical and Technical sciences |
| Address |
Department of Periodontics and Implantology, Clinic-25, 4th floor, Saveetha Dental College and Hospitals,162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu- 600077.
Thiruvallur TAMIL NADU 600077 India |
| Phone |
8220694720 |
| Fax |
|
| Email |
mohamedthaha9991@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kaarthikeyan G |
| Designation |
Professor And Head of Department |
| Affiliation |
Saveetha Institute of Medical and Technical sciences |
| Address |
Department of Periodontics and Implantology, Clinic-25, 4th floor, Saveetha Dental College and Hospitals 162, Poonamalle High Road, Velappanchavadi, Chennai, Tamil Nadu- 600077.
Thiruvallur TAMIL NADU 600077 India |
| Phone |
9841222027 |
| Fax |
|
| Email |
kaarthikeyan@saveetha.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kaarthikeyan G |
| Designation |
Professor And Head of Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Periodontics and Implantology, clinic 25, 4th floor, Saveetha Dental College and Hospitals, 162, Poonamalle High Road, Velappanchavadi,Chennai, Tamil Nadu, India- 600077. 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India- 600077 Thiruvallur TAMIL NADU 600077 India |
| Phone |
9841222027 |
| Fax |
|
| Email |
kaarthikeyan@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology, Clinic 25, Saveetha Dental College and Hospitals, Chennai, Tamil Nadu, India - 600077 |
|
|
Primary Sponsor
|
| Name |
Dr Ashish Jain Indian Society of Periodontology |
| Address |
Secretary ISP, 721, Phase 3B-1, Mohali, SAS Nagar. 160060. |
| Type of Sponsor |
Other [Speciality society in Dentistry] |
|
|
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 Mohamed Thaha A |
Saveetha Dental college and Hospitals |
Department Of Periodontics and Implantology, clinic 25, 4th floor,162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India-600077 Thiruvallur TAMIL NADU |
8220694720
mohamedthaha9991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional free hand Implant placement. |
Immediate placement of dental implant following vestibular socket protocol by conventional free hand placement for period of 6 months |
| Intervention |
Dynamic navigation system |
Immediate placement of dental implant following vestibular socket protocol using Dynamic navigation system for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The tooth in the Maxillary anterior region which had undergone trauma, has root fracture or non-vital teeth with thin labial plate /dehiscence which is indicated for extraction and immediate implant placement |
|
| ExclusionCriteria |
| Details |
Periapical lesions, smokers, pregnant and lactating women, and patients with systemic conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Buccal wall Thickness and marginal bone loss. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pink and white esthetic score |
6 months post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Immediate implants placed conventionally have a high chance of encroaching the safe zone which results in both soft and hard tissue complications in the long run. By using this VST method, we can augment both hard and soft tissue at the extraction site. By using a Dynamic navigation system precise implant placement at 360° in esthetic areas, offering real-time adjustments during osteotomy for enhanced accuracy compared to static guides. The study is a randomized controlled clinical trial proposed to be done in the Department of Periodontics, Saveetha Dental College and Hospitals, Chennai. After patient recruitment, the patients are allotted using lot sampling and patient will be made to pick up the concealed envelop are divided into subsequent groups- a)The control group is going to be the participants who will be receiving conventional immediate implants via VST. b)The test group will be receiving implants through DNS via VST. Technique: Perform vestibular socket therapy by incising 1 cm apical to the tooth. Dissect vestibular pouch towards root apex for access. Use bur for osteotomy at the apex and release the ligament. Elevate root fragments and excavate apex. Place the implant with 360-degree contact using the DNS system. Use xenograft in bone defects with GBR membrane. Suture with 4-0 polypropylene and provide permanent prosthesis after period of temporization. The data from results are compared using Student’s T-test and One-way ANOVA. The primary objective is to assess buccal wall thickness and marginal bone loss between the two groups. The pink esthetic score and white esthetic score are also assessed secondarily. |