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CTRI Number  CTRI/2025/03/082519 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of Bone Mineral Density and Primary Implant Stability using Bonegraft and Platelet Rich Fibrin with or without Laser Assisted Socket Preservation 
Scientific Title of Study   Comparative evaluation of Bone Mineral Density and Primary Implant Stability with Sandwich Technique using Perioglass and Platelet Rich Fibrin with or without Laser Assisted Socket Preservation: A Randomized Controlled Clinical and Radiographical 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 Dipanshu Pahuja 
Designation  Post Graduate student 
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  V.Y.W.S DEntal college and hospital, Amravati Room no.16, Department of PEriodontology, Topavan-Wadali road,SRPF colony, Amravati 444602

Amravati
MAHARASHTRA
444602
India 
Phone  9405978744  
Fax    
Email  dipanshupahuja1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Parwani  
Designation  HOD and Professor  
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  V.Y.W.S DEntal college and hospital, Amravati Room no.16, Department of PEriodontology, Topavan-Wadali road,SRPF colony, Amravati 444602

Amravati
MAHARASHTRA
444602
India 
Phone  9977132697  
Fax    
Email  simpar74@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dipanshu Pahuja 
Designation  Post Graduate student 
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  V.Y.W.S DEntal college and hospital, Amravati Room no.16, Department of PEriodontology, Topavan-Wadali road,SRPF colony, Amravati 444602

Amravati
MAHARASHTRA
444602
India 
Phone  9405978744  
Fax    
Email  dipanshupahuja1@gmail.com  
 
Source of Monetary or Material Support  
VYWS Dental College and Hospital, Amravati, Topovan-wadali road, SRPF camp road, Amravati 444602 
 
Primary Sponsor  
Name  Dr Dipanshu Pahuja 
Address  VYWS Dental College and Hospital, Amravati, Tapovan-Wadali road, SRPF colony, Amravati 444602 
Type of Sponsor  Other [self sponsored] 
 
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 Dipanshu Pahuja  V.Y.W.S. Dental College and Hospital, Amravati  Room NO. 16, Department of Periodontology, VYWS Dental College and Hospital, Amravati
Amravati
MAHARASHTRA 		 9405978744

dipanshupahuja1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-VYWSDCHA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Socket preservation by Bone Graft and PRF  Socket preservation in relation to the extracted tooth will be done using a sandwich technique. This will include: first gently condensing the apical 1/3rd of the socket with pieces of PRF, subsequently packing the middle and coronal 1/3rds of the socket with a blend of PRF pieces and Perioglass synthetic Bone Graft material, and at the coronal end, covering the socket with a PRF membrane. The membrane will be tucked into the socket to conceal the graft and contain it within the socket as the healing takes place and horizontal mattress sutures will be given to secure grafted materials. Done the socket preservation at baseline and check the parameters after four months 
Intervention  Socket preservation by Bone Graft and PRF along with laser  Laser therapy will be rendered in two forms: Contact mode and non-contact mode. Contact mode is the tip of soft tissue cutting diode laser (980 nm) will be employed by sweeping on all the surfaces of the extraction socket with Implant field sterilization mode at 2 Watt power pulsed mode for 10 seconds followed by Non-contact mode Photobiomodulation using Low Level Laser Therapy with same laser but changed handpiece, 1 square centimeter spot size, 3 Watt power pulsed mode for 20 seconds, which will be performed on socket immediately after extraction; subsequently, the socket will be preserved in the similar manner as in control group. After eight days, Low Level Laser Therapy will be repeated. Done at baseline and check the parameters after four months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants in the age range of 18 to 65 years
Participants having good oral hygiene
Presence of tooth or root piece indicated for extraction
Participants willingness for implant placement
 
 
ExclusionCriteria 
Details  Any contraindication for surgery:
Acute infection
Medically compromised patients
Uncooperative patients
Non-compliant patients for oral hygiene maintenance
Subjects with abnormal bleeding/clotting time
Presence of any pathology causing facial bony plate dehiscence
History of Irradiation in Head and Neck
Uncontrolled diabetic patients (reported levels of glycemia over the normal threshold)
Current pregnancy or lactation
Current Smokers
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Maximum Bucco-lingual width of the socket at the time of socket preservation and at the time of implant placement will be measured using ridge measuring pliers clinically and radiographically with CBCT.
2. Pain Scores using VAS scale within 24 hours after extraction and socket preservation in both the groups.
3. Bone mineral density will be evaluated after four months of socket preservation radiographically by CBCT.
4. Primary implant stability will be evaluated at the time of implant placement by insertion torque value (ITV)
5. Clinical signs of inflammation (bleeding on probing, plaque index, gingivitis index, probing pocket depth and percussion test) after six months of implant placement will be recorded in both the groups.
6. Radiographic analysis evaluating peri-implant bone loss at six months post-implant placement in both the groups.
 		 Baseline and four months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   30/03/2025 
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="9"
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  

Krizaj et al. (2020)10 performed  a study to evaluate a comprehensive laser post-extraction protocol by comparing results of alveolar bone regeneration with standard extraction procedure alone versus when added with laser therapy. 53 simple extractions were randomized to either laser or control group. In the laser group, erbium (Er:YAG; 2940 nm) and neodymium (Nd: YAG; 1064 nm) lasers were used for degranulation, disinfection, de-epithelialization of the surrounding gingiva, clot stabilization and photobiomodulation. The primary outcome measure was change in bone density in the extraction area between day 1 and 4 months after extraction. The study concluded that the proposed laser post-extraction procedure is a safe and effective method to improve post-extraction bone healing.

Monea et al. (2015)11 conducted a study to determine whether low level laser therapy (LLLT) can decrease the time between extraction/socket graft and implant placement, by evaluating histological changes in sockets grafted with a particulate allograft material and treated with LLLT. Thirty patients had a socket grafted with a particulate allograft material (MinerOss) covered with a resorbable collagen wound dressing. The patients were then randomly divided into two equal groups (n = 15): test group receiving postoperative LLLT treatment, and control group without postoperative laser treatment. The assessment of bone formation was carried out in both groups at well-determined time intervals after surgery by histomorphometric analysis. The study concluded that LLLT photobiomodulation reduces the healing time after grafting the extraction socket. Histological evidence suggested that new bone formation in the sockets appeared within 60 days after LLLT treatment compared to a minimum of 120 days in the control group.
 
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