| CTRI Number |
CTRI/2025/10/095802 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using light therapy to improve dental implant fixation and bone Healing by preserving the natural tooth root |
|
Scientific Title of Study
|
Efficacy of Photobiomodulation (PBM) on stability and crestal bone remodelling in immediate implant placement following socket shielding technique: 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 Reyya Arun Prakash |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental college |
| Address |
PG clinic room no:8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
6304868704 |
| Fax |
|
| Email |
arunprakash.r@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A V Rama Raju |
| Designation |
Principal |
| Affiliation |
Vishnu Dental College |
| Address |
Principal office, Block 1, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848026081 |
| Fax |
|
| Email |
ramarajuav@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A V Rama Raju |
| Designation |
Principal |
| Affiliation |
Vishnu Dental College |
| Address |
PG clinic room no:8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848026081 |
| Fax |
|
| Email |
ramarajuav@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental Coellege, Vihnupur, Bhimaavaram, West Godavari, Andhra Pradesh, 534202, India |
|
|
Primary Sponsor
|
| Name |
Dr Reyya Arun Prakash |
| Address |
Vishnu dental College, Sri Vishnu Educational Society, Bhimavaram, West Godavari, Andhra Pradesh, India 534202 |
| Type of Sponsor |
Other [Self] |
|
|
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 Reyya Arun Prakash |
Vishnu Dental College |
PG clinic room no:8, Department of Prosthodontics, Block 2, First floor, Vishnupur, Bhimavaram-534202 India
West Godavari
ANDHRA PRADESH |
6304868704
arunprakash.r@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photobiomodulation |
After preparation of socket shield and osteotomy site preparation using implant drills, photobiomodulation using 810nm diode laser for 60seconds and 10mW power will be done following implant placement |
| Comparator Agent |
Socket Shield implant |
After preparation of socket shield and osteotomy site preparation using implant drills, implant placement will be done |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with age 20 – 60 years.
2.American Society of Anaesthesiologists (ASA) I category.
3.Bilateral or unilateral with one or more teeth advised for extraction in the maxillary single rooted teeth region.
4.Non-restorable carious lesion.
5.Fairly intact buccal periodontal tissues.
6.Any periodontal phenotype (thin or thick) was included.
|
|
| ExclusionCriteria |
| Details |
1.Patients subjected to radiotherapy in the head and neck.
2.ASA – II, III, IV, V patients.
3.Teeth with Periodontal disease, fracture involving the alveolus and mobile teeth.
4.Active local or systemic infection.
5.Roots extending into maxillary sinus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impant Stability |
Implant Stability at 0, 3, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Crestal bone remodelling |
Basal line and 6th month |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
20/10/2025 |
| 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="0"
Months="6"
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
|
Title Efficacy of Photobiomodulation on stability and crestal bone remodelling in immediate implant placement following socket shielding technique: Randomised Controlled Clinical Trial
Introduction
Socket shielding was introduced to preserve buccal bone after extraction by leaving a thin root fragment as a barrier.
Photobiomodulation (PBM) uses low-level red or near-infrared light to accelerate tissue regeneration, reduce inflammation, and improve bone and soft tissue healing around implants.
Combining socket shielding with PBM aims to improve implant stability and maintain bone and aesthetics.
Problem Statement
Socket shield technique may face issues like shield exposure and root fragment resorption due to inflammation.
PBM can minimize inflammation and promote osseointegration.
Need for study
Limited literature compares bone changes and implant stability in socket shielding with and without PBM.
Aim To evaluate and compare crestal bone remodelling and implant stability between conventional socket shielding and socket shielding with PBM.
Objectives
Compare implant stability quotients at baseline, 1 month, and 3 months.
Compare crestal bone remodelling at baseline and 6 months.
Hypothesis
Null: No difference between the two groups.
Research: PBM will improve stability and bone preservation.
Research Question Will there be a difference in implant stability and crestal bone remodelling between conventional socket shielding and socket shielding with PBM in maxillary single-rooted teeth?
Sample Size
Final sample size: 22 subjects (11 per group).
Inclusion Criteria
Patients 20–60 years, ASA I, single-rooted maxillary teeth for extraction, intact buccal tissues, any periodontal phenotype.
Exclusion Criteria
Patients with systemic diseases, radiotherapy, active infection, teeth with alveolar fracture, or roots into sinus.
Methodology
Random allocation into experimental and control groups.
Informed consent, CBCT assessment, plaque control.
Socket shield preparation and implant placement.
Experimental group: PBM with diode laser (810 nm, 10 mW, 60 sec).
Suturing and follow-up.
Follow-up
Implant stability: 0, 1, 3 months.
Crestal bone levels: 6 months via CBCT.
PBM second session during suture removal.
Statistical analysis using ANOVA, t-test, or Friedman’s test.
Outcome
Expected to show improved implant stability and crestal bone preservation with PBM. |