| CTRI Number |
CTRI/2024/05/067565 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Analysis of Bone changes in patients rceving three differing implant designs |
|
Scientific Title of Study
|
A Comparative Evaluation of Mean Crestal Bone Level Changes among Hydrophobic, Hydrophilic, and Laser Micro-Grooved Dental Implants Post 1 Year of Immediate Loading – A Randomised Clinical Control 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 |
Dr Dhivya Dharshini K |
| Designation |
Post graduate resident |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department Of Periodontics,
3rd Floor PG Block,
PG Clinic,
SRM Dental College,
Bharathi Salai,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
8248533753 |
| Fax |
|
| Email |
dhivyadkrishna77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PSG Prakash |
| Designation |
Professor SRMDC |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department Of Periodontics,
3rd Floor PG Block,
PG Clinic,
SRM Dental College,
Bharathi Salai,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PSG Prakash |
| Designation |
Professor SRMDC |
| Affiliation |
SRM Dental College |
| Address |
Department Of Periodontics,
3rd Floor PG Block,
PG Clinic,
SRM Dental College,
Bharathi Salai,
Ramapuram,
Chennai.
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Periodontics,
3rd Floor PG Block,
PG Clinic,
SRM Dental College,
Bharathi Salai,
Ramapuram,
Chennai. |
|
|
Primary Sponsor
|
| Name |
self funding |
| Address |
Dr Dhivya Dharshini
1st year post graduate student
Department of Periodontics
Pg Block
Pg Clinic
3rd floor
SRM DENTAL COLLEGE
Bharathi Salai
Ramapuram
Chennai
Pincode: 600089 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Dhivya Dharshini k |
SRM Dental College |
Department of periodontics
PG block
3rd floor PG clinic
SRM Dental College
Bharathi Salai
chennai 600089
Chennai
TAMIL NADU |
8248533753
dhivyadkrishna77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD SRM 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 |
Control group-1 |
SLA implants will be placed in healthy individuals for management of edentulous sites in mandible
clinical parameters will be evaluated at Baseline, 6 months, 1 year time intervals
Radiographic parameters are evaluated from baseline to 1 year |
| Intervention |
Test Group-1 |
Hydrophilic implants (SLA Active) will be placed in healthy individuals for management of edentulous sites in mandible
clinical parameters will be evaluated at Baseline, 6 months, 1 year time intervals
Radiographic parameters are evaluated from baseline to 1 year |
| Intervention |
Test group-2 |
Laser Microgrooved Dental implants will be placed in healthy individuals for management of edentulous sites in mandible
clinical parameters will be evaluated at Baseline, 6 months, 1 year time intervals
Radiographic parameters are evaluated from baseline to 1 year |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients with age group between 25 to 60 years
Patients not contraindicated for periodontal or implant surgery
One bounded edentulous space ie a single tooth missing with intact proximal teeth primarily in the lower posteriors premolars and molars with sufficient bone quantity to allow implant placement
Patients should be cooperative motivated and oral hygiene conscious
Sufficient bone height at least 13mm and sufficient bone width at least 6mm should be present
Presence of local factors without signs of clinical inflammation
Stable occlusion with no para functional habits
|
|
| ExclusionCriteria |
| Details |
Presence of active periodontal disease at the time of implant surgery
Patients who did not accept to comply for 1 year follow-up were excluded from the study
Patient diagnosed with known systemic diseases Bone disorders like hyperparathyroidism osteoporosis or Pagets disease
Patients who are under steroids antiinflammatory and bisphosphonates in the past 6 months
Patients who are treated with radiotherapy or chemotherapeutic agents.
Chronic alcoholics or drug abuse
Smokers
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Crestal bone level changes in mm to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control SLA and Test groups SLA-Active and LMGI
Implant survival rates in percentage to be assessed at 1 year with radiographic and clinical assessment between Control SLA and Test groups SLA Active and LMGI
|
subjects will be followed at baseline, 6 months and 1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the Relative position of gingival margin in mm at the implant site of Control SLA and Test groups SLA-Active and LMGI at Baseline 6 months and 1 year post loading
To assess the Implant stability quotient ISQ values using resonance frequency analysis RFA during Immediate Loading protocol
|
subjects will be followed at baseline, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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)
|
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 have emerged as a popular option for replacing missing teeth due to their biocompatibility and ability to provide a stable foundation for replacement teeth. While Moraschini et al. (2015) showed high success rates over 10 years, there’s a gap in comparing implant designs like hydrophobic (SLA), hydrophilic (SLA active), and Laser Microgrooved Implants (LMGI). This research needs to address long-term bone level changes, particularly the Mean Crestal Bone Level (MCBL), which is crucial for assessing implant success (Jamcoski et al., 2022). This gap indicates a need for groundbreaking research to address the lack of evidence on long-term bone level changes associated with these micro designs. The lack of literature comparing the Mean Crestal Bone Level changes among Hydrophobic, Hydrophilic, and Laser Micro-Grooved Dental Implants Post 1 Year of Immediate Loading underscores the need for novel research in this area. The aim of this study is to evaluate and compare the Mean Crestal bone level changes in Hydrophilic, Hydrophobic and Laser Micro grooved dental implants post 1-year immediate loading. Though there are multitude of evidences to favor these micro-modifications and their implications on Mean Crestal Bone level changes individually, there are scarcity in the literature on comparison of various micro modified implant systems. To the best of our knowledge there are no literature evidence comparing these there primitive micro-modified implant designs in specific i.e., hydrophobic (SLA), hydrophilic (SLA active) and laser micro-grooved implants. Thus, comparison of these three primitive microdesigns i.e., hydrophobic (SLA), hydrophilic (SLA active) and Laser Microgrooved Implants (LMGI) would be a ground breaking and forefront evidence to fill the lacunae pertaining to the evidences evaluating long term bone level changes in relevance to these three microdesign. Such evidence would be definitive clinical guideline in appropriate implant selection entailing the specific anatomical demands |