FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
Close