| CTRI Number |
CTRI/2025/07/090922 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on Comparing healing after root end surgery with and without low level laser therapy. |
|
Scientific Title of Study
|
Clinical and radiographic assessment of soft and hard tissue healing with low level laser therapy following endodontic surgery: A randomized clinical 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 |
Dr Anshuman Rai |
| Designation |
Junior Resident(Conservative Dentistry and endodontics |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative dentistry and Endodontics ,Faculty of Dental Sciences , King Georges Medical University Lucknow
Lucknow UTTAR PRADESH 226003 India |
| Phone |
7217733089 |
| Fax |
|
| Email |
anshumanraidec619@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh Bharti |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative dentistry and Endodontics ,Faculty of Dental Sciences , King Georges Medical University Lucknow
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9935724723 |
| Fax |
|
| Email |
rameshbharti@kgmcindia.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Promila Verma |
| Designation |
Professor and Head |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative dentistry and Endodontics ,Faculty of Dental Sciences , King Georges Medical University Lucknow
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9415542063 |
| Fax |
|
| Email |
promilarajesh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, King Georges Medical University, Lucknow, 226003,Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Anshuman Rai |
Faculty of Dental Science, King Georges Medical University, Lucknow |
First Floor , Old Dental Building , department of Conservative dentistry and Endodontics, Lucknow 226003 Lucknow UTTAR PRADESH |
7217733089
anshumanraidec619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K046||Periapical abscess with sinus, (2) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Level Laser Therapy |
Low Level Laser therapy (808nm, 100mW and 4J/cm2) application will be made in the immediate post operative period and for three visits every alternate day after endodontic surgery with an irradiation time of 120 seconds over the periapical tissues of involved tooth along with standard post surgical care. |
| Comparator Agent |
No Low Level Laser Therapy |
No low level laser therapy intervention given, only standard post surgical care followed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients within 18-40 years of age.
2. Single rooted, anterior teeth with periapical radiolucency indicated for surgery.
3. patients who are not on any medication affecting periapical healing.(Corticosteroids, chemotherapeutic agents, non steroidal anti inflammatory drugs, antibiotics, anticoagulants and drugs which reduce osteoclastic activity). |
|
| ExclusionCriteria |
| Details |
1.Patients who did not give their consent for participating in the study.
2.Patients with any systemic diseases like diabetes mellitus, hypertension, hepatitis, Human
immunodeficiency virus, bone disorders, auto immune disorders.
3. Surgical retreatment cases.
4. Patients with malignant tumors or undergoing chemotherapy, radiotherapy.
5. Pregnant females.
6. Patients with periodontally compromised teeth. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate change in the size of the periapical defect after endodontic surgery following low level laser therapy. |
At baseline, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Neo-angiogenesis in the periapical defect after endodontic surgery using color doppler. |
At baseline, 3 month & 6 month |
|
|
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)
|
31/07/2025 |
| 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="1" 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
|
Apical surgery
is considered a standard oral surgical procedure. It is often a last resort to
surgically maintain a tooth with a periapical lesion that cannot be managed
with conventional endodontic (re-)treatment. The main goal of apical surgery is
to prevent bacterial leakage from the root-canal system into the periradicular
tissues by placing a tight root-end filling following root-end resection.1
The success of
periapical surgery has been assessed with the same clinical and radiographic
criteria as for nonsurgical root canal treatment. However, many previous
studies stated that the radiographic rate of bone regeneration for successful
periapical healing after endodontic surgery are different from those for
nonsurgical root canal treatment.2,3
To further
enhance the rate of Radiographic and clinical outcome following endodontic
surgery many advancements have been introduced in the field of dentistry, one
such advancement is the use of Low Level Laser therapy. The use of Low-Level
Laser Therapy (LLLT) is known to influence the healing process through
biostimulation, helping to reduce pain and swelling without any side effects,
while promoting tissue healing.7 Numerous controlled studies have
demonstrated the beneficial effects of LLLT at both the cellular and
histological levels.10,11 LLLT induces vasodilation, which enhances
local blood circulation11, bringing more oxygen to the area and
promoting the migration of immune cells to the affected tissue. Additionally,
it causes relaxation of the smooth muscle in the blood vessel walls, further
accelerating tissue repair.19
The radiographic
assessment of Low Level Laser therapy in regards with its outcome on healing of
hard tissue is done using CBCT, though Conventional radiography is the most
common and routine radiographic procedure employed still it does not provide
conclusive evidence on the extent or limits, dimensions, content of the lesions.22,23
3D compression , geometric alterations of anatomic structures and obscuring
important anatomic details.
Cone Beam
Computed Tomography (CBCT) is an advanced imaging technique that offers precise
three-dimensional (3D) view of the maxillofacial complex tissue structures and
the relationship among anatomical structures. Using CBCT in endodontics enables
a three dimensional comprehensive evaluation of the area of interest and
improved resolution, providing a detailed analysis of the tooth and surrounding
tissue. Furthermore, CBCT offers excellent dimensional accuracy with only about
2% magnification, making it an ideal tool for diagnostic purposes.12
To assess the
enhancement of blood circulation and neoangiogenesis in the area of defect
Colour Doppler Ultrasonography is used. During the first healing phase, new
blood vessels in the bone gradually form. Angiogenesis is a critical component
of bone repair. Inflammatory cells, precursor cells, and the metabolically
active regenerating callus are recruited to the injury site with the help of
essential nutrients and oxygen supplied by the newly developing blood vessels.
Therefore, using Colour Doppler in this study will enable us to assess
neo-vascularisation, a vital process in bone healing.
The goal of this
study is to thoroughly investigate the potential clinical and radiographical
advantages of LLLT in improving the healing of both soft and hard tissues
following endodontic surgery.4
AIMS AND OBJECTIVES:
Aim:
The aim of this randomized study is to
evaluate possible benefits of Low Level Laser therapy (LLLT) on soft and hard
tissue healing after endodontic surgery.
The
study had the following objectives:
Primary
Objective:
·
To assess the clinical and radiographic
outcomes of Low Level Laser Therapy on soft and hard tissue healing post
endodontic surgery.
Secondary
Objective:
·
Radiographic and Ultrasonographic investigation
for possible association of bone regeneration following low level laser
therapy. MATERIALS AND METHODS:
The present study will be conducted in the
Department of Conservative Dentistry and Endodontics, Faculty of Dental
Science, King George’s Medical University, Lucknow in collaboration with Department
of Radiodiagnosis and Department of Oral Medicine and Radiology, KGMU, Lucknow.
The study will be conducted only after
getting clearance from Institutional Ethical Committee and registration in
CTRI.
Suitable number of patients with
periapical bone defects who will give the written consent will be selected and
randomized into 2 test groups.
Periapical endodontic surgery will be
performed in all the groups. Following the periapical surgery one Group will be
subjected to Low Level Laser Therapy following a specific protocol at regular
interval. The results will be evaluated against a control group in which no Low
Level Laser Therapy will be given.
Clinical and radiographic evaluation of
these patients will be done at required time interval.
The
obtained data will be subjected to statistical analysis.
Any changes if found necessary will be
done in the interest of the study.
|