| CTRI Number |
CTRI/2026/03/105320 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Smoking on Bone Changes Around Different Dental Implant Designs |
|
Scientific Title of Study
|
Comparative Evaluation Of Crestal Bone Level Changes Between Hydrophobic, Hydrophilic, And Laser Micro-Grooved Dental Implants Using Minimally Invasive Flapless Technique In Smoker Individuals – A Randomised Controlled 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 |
Dr C ANNE KIRUBA |
| Designation |
Post graduate resident |
| Affiliation |
SRM Dental college , Ramapuram |
| Address |
Department of Periodontics,4th floor PG block,PG clinic,SRM dental college, Bharathi Salai, Ramapuram, chennai,
TAMILNADU
600089
INDIA
Chennai
TAMIL NADU
600089
India |
| Phone |
9442250741 |
| Fax |
|
| Email |
ann20chris@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PSG Prakash |
| Designation |
Professor SRMDC |
| Affiliation |
SRM Dental college , Ramapuram |
| Address |
Department of Periodontics,4th floor PG block,PG clinic,SRM dental college, Bharathi Salai, Ramapuram, chennai,
TAMILNADU
600089
INDIA
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 , Ramapuram |
| Address |
Department of Periodontics,4th floor PG block,PG clinic,SRM dental college, Bharathi Salai, Ramapuram, chennai,
TAMILNADU
600089
INDIA
Chennai
TAMIL NADU
600089
India |
| Phone |
9840870990 |
| Fax |
|
| Email |
akashpsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics, PG block, PG clinic, 4th floor, SRM DENTAL COLLEGE, Bharathi Salai, Ramapuram, Chennai, 600089 |
|
|
Primary Sponsor
|
| Name |
C ANNE KIRUBA |
| Address |
Dr. Anne Kiruba ,
1st yr post graduate student,
department of periodontics, PG block, PG clinic, 4th floor, SRM DENTAL COLLEGE, Bharathi Salai, Ramapuram, Chennai, 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 C ANNE KIRUBA |
SRM Dental College |
Department of periodontics, PG block, 4th floor PG clinic,
SRM Dental College ,
Bharathi Salai,
Ramapuram,
Chennai
600089
Chennai
TAMIL NADU |
9442250741
ann20chris@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: K050||Acute gingivitis, (2) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
smoker Patients with isolated edentulous receiving Hydrophobic implants (Sand blasted large grid acid etched implants- Neoporous surface – SLA) |
| Intervention |
test group 1 |
smoker Patients with isolated edentulous receiving Hydrophilic implants (Sand blasted large grid acid etched implants with aqua surface - SLA active) |
| Intervention |
test group 2 |
smoker Patients with isolated edentulous receiving Laser Micro Grooved implants (LMG) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 25 and 60 years will be included in the study
2. One bounded edentulous space i.e., a single tooth missing with intact proximal teeth primarily in the lower posteriors (premolars and molars) with sufficient bone quantity to allow implant placement.
3. Patients should be cooperative, motivated and oral hygiene conscious.
4. Only patients with adequate bone height of at least 13 mm and bone width of at least 6 mm will be included.
5. Patients with healthy adjacent teeth and stable periodontal status will be considered for inclusion.
6. current smokers were included only if their exposure was classified as mild, defined as fewer than 10 cigarettes per day and a cumulative history of less than 0.5 pack-years.
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled systemic diseases such as diabetes, immunocompromised conditions, or bleeding disorders.
2. Patients who have a history of taking bisphosphonates, corticosteroids, immunosuppressive drugs, or anticoagulants will be excluded.
3. Patients with active periodontal disease or untreated oral infections will be excluded.
4. Patients who require bone grafting or ridge augmentation procedures will be excluded.
5. Patients exhibiting parafunctional habits such as bruxism or clenching will be excluded.
6. Pregnant or lactating women will be excluded from the study.
7. Patients who have undergone radiotherapy in the head and neck region or chemotherapy will be excluded.
8. Patients with known allergy to titanium or implant-related materials will be excluded.
9. Patients who are unwilling or unable to comply with oral hygiene instructions will be excluded.
10. Patients with a history of failed implant placement at the intended site will be excluded.
11. Patients who do not comply for 1 year follow up are excluded |
|
|
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 |
1) Mean Crestal bone level changes (mm) to be assessed at Baseline and 1 year with standardized Intra oral periapical radiographs in Control (SLA) and Test groups (SLA-Active & LMGI).
2) Implant survival rates (%) to be assessed at 1 year with radiographic and clinical assessment between Control (SLA) and Test groups (SLA Active & LMGI).
|
baseline and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate and compare the Relative position of gingival margin (mm) at the implant site of Control (SLA) and Test groups (SLA-Active and LMGI) at Baseline, 6 months and 1 year post loading |
baseline , 6 months and 1 year |
2. To assess the Implant stability quotient (ISQ) values using resonance frequency analysis (RFA) during Early Loading protocol.
3. To assess the Early Wound Healing Index (EWHI) using Huang et al index (2005) at the 1st week, 2nd week, and 4th week during the Early Loading protocol, comparing the Control (Hydrophobic) and Test groups (Hydrophilic and Laser Micro-Grooved Implants).
4. To assess and compare Patient Reported Outcome Measures (PROMs) like pain scale using Visual Analog Scale at 1 week
|
1st week, 2nd week, 4th week, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/03/2026 |
| 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
|
This study evaluates how microgeometrical surface modification of dental implants impacts stability, crestal bone preservation, peri-implant health, and implant survival, particularly in smoker patients. These findings will provide insights to optimize implant selection, treatment planning, and patient care, contributing to improved long-term success and patient outcome. |