| CTRI Number |
CTRI/2025/08/092562 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Bone Loss Around Dental Implants With and Without the Use of Low-Level Laser Therapy, Checked Through 3D X-rays and Clinical Exams |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss around dental implants with and without low level laser irradiation: a clinico-radiographic cbct 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 |
Nitin Tomar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Subharti Dental College and hospital
Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Tomar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Subharti Dental College and Hospital
Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Tomar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology and Implantology, Subharti Dental College and hospital.
Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology and Implantology, Subharti Dental College and Hospital, Meerut, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Tripathy |
| Address |
Subharti Dental College Swami Vivekanand Subharti University Subhartipuram NH 58 Delhi Haridwar Bypass Road Meerut Uttar Pradesh India 250005 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nitin Tomar |
Subharti Dental College, Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi-Haridwar Bypass Road, Meerut. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishwarya Tripathy |
Subharti Dental College and Hospital |
Room No.2,Department of Periodontology, Subharti Dental College and Hospital, NH-58, Delhi-Haridwar Bypass Road 250005
Meerut
UTTAR PRADESH |
8377909000
aish.trip2703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
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 |
The osteotomy site will not be irradiated with low level laser. |
| Intervention |
TEST GROUP
|
Osteotomy site will be irradiated with low level laser at 6 sites for 9 seconds each. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having single missing tooth with an adequate width and height of edentulous space available for placement of implant.
2.Edentulous sites in mandibular and maxillary arches.
3.Adjacent teeth intact, restored with functionally and esthetically good restorations, restored with prosthesis precluding the addition of the missing tooth.
4.Patients with good periodontal and general health. |
|
| ExclusionCriteria |
| Details |
1.Patients who are unable to perform routine oral hygiene procedures.
2.Patients with history of smoking.
3.Patients with TMJ disorders.
4.Patients with dental history of bruxism and parafunctional habits or deep bite cases.
5.History of substance abuse.
6.Insufficient vertical inter arch spaces to accommodate the prosthodontic components available, together with a proposed pontic and occasional gingival analogue designs.
7.Patients with uncontrolled diabetes.
8.Absence of opposing occlusion. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cretal Bone Loss Around Dental Implants. |
Baseline, 4 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue changes around dental implants |
4 months and 9 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/08/2025 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study we will be randomly selecting 20 patients according to the inclusion and exclusion criteria. 10 patients will be in the test group in which they will be given low level laser therapy around the osteotomy site immediately after implant placement then after 48 hours, 7th day and 14th day. 10 patients will be in the control group in which they will not be given low level laser therapy. After the placement of the implant, RVG and CBCT will be recorded at baseline. The patient will be recalled after 4 months and 9 months. Then RVG and CBCT will be repeated and the data will be collected. The data of both the groups will be statistically analyzed and the results will be obtained. |