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CTRI Number  CTRI/2024/05/067302 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of demineralized freeze-dried bone allograft combined with low-level laser therapy using single-flap approach technique for treating intrabony defects 
Scientific Title of Study   Effect low-level laser therapy as an adjunct to single flap approach technique in the treatment of intrabony defects using demineralised freeze-dried bone allograft 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Golapala naga aishwarya 
Designation  pg student 
Affiliation  Sibar institute of dental sciences 
Address  Room no.8,department of periodontics,sibar institute of dental sciences,takellapadu,guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  07093156626  
Fax    
Email  aishwaryagolapala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anumala deepa 
Designation  professor 
Affiliation  Sibar institute of dental sciences 
Address  Room no.8,department of periodontics,sibar institute of dental sciences,takellapadu,guntur,

Guntur
ANDHRA PRADESH
522509
India 
Phone  9618501146  
Fax    
Email  anumala.deepas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anumala deepa 
Designation  professor 
Affiliation  Sibar institute of dental sciences 
Address  Room no.8,department of periodontics,sibar institute of dental sciences,takellapadu,guntur,

Guntur
ANDHRA PRADESH
522509
India 
Phone  9618501146  
Fax    
Email  anumala.deepas@gmail.com  
 
Source of Monetary or Material Support  
Sibar institute of dental sciences,takellapadu,guntur,andhra pradesh,india,522509. 
 
Primary Sponsor  
Name  Golapala naga aishwarya 
Address  Room no.8,department of periodontics,sibar institute of dental sciences,takellapadu,guntur, 
Type of Sponsor  Other [Self] 
 
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 
Golapala naga aishwarya  Sibar institute of dental sciences  Room no.8,department of periodontics,sibar institute of dental sciences,takellapadu,guntur,
Guntur
ANDHRA PRADESH 
07093156626

aishwaryagolapala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DFDBA placed in intrabony defects  DFDBA will be placed in intrabony defects with single flap approach procedure.follow up after 2weeks,3months,6months. 
Intervention  low-level laser therapy with DFDBA in intrabony defects  DFDBA will be placed in the intrabony defects using low level Laser therapy with single flap approach procedure.follow up after 2weeks,3months,6months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Patients of age 25 – 55 years.
2 Apparently healthy patients.
3 Probing depth of≥6mm.
4 Patients with Interproximal 2 or 3 wall intrabony defect in the posterior teeth with radiographic evidence of vertical bone loss ≥3mm.
5 Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  1 Presence of any systemic disease.
2 Pregnant women and lactating mothers.
3 Use of any form of tobacco.
4 Having habits like bruxism and night clenching
5 Having history of drug usage and allergy
6 Patients who are under periodontal therapy from the past 6months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Early healing index (EHI),Radiographic bone gain measurement  Baseline,2weeks,3months,6months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced Probing Pocket depth ,Clinical attachment level,Gingival recession depth   Baseline,3months,6months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/06/2024 
Date of Study Completion (India) 06/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Periodontitis is an infectious disease, resulting in inflammation within the supporting tissues of the teeth which lead to periodontal pocket deepening, loss of attachment and bone. Intrabony defects are those with apical location of base of the pocket relative to bone crest.Demineralized freeze‐dried bone allograft (DFDBA) is an allograft that harbor’s a variety of growth/differentiation factors, notably bone morphogenetic proteins (BMPs) 2, 4, and 7.Single-flap approach (SFA) is one of the periodontal flap designs proposed to minimize the surgical trauma.LLLT is based on the biostimulation effect, which is based on the fact that cellular behavior can be changed by irradiation at a particular wavelength. Both SFA and LLLT have beneficial effects on probing pocket depth reduction, periodontal wound healing, and obtaining clinical attachment.All the recruited patients will be receiving phase I therapy which includes scaling and root planing which will be performed by single operator. Oral hygiene instructions will be given. Two weeks after SRP all clinical and radiological parameters will be recorded.A buccal envelope flap will be made using Sulcular incisions in the surgical area following the gingival margin of the teeth.Upon completion of the root instrumentation, defect depth, defect width, and wall present will be measured. Control group will receive only DFDBA biomaterial after surgical debridement. In the test group LLLT (Diode laser, Woodpecker) irradiation with 976‐nm wave length at 1.5 W, continuous wave for 5s before surgical debridement will be done and DFDBA biomaterial will be placed.At wound closure vertical internal mattress suture will be placed.Sutures will be removed after two weeks and EHI wound healing index will be recorded. The surgical site will be evaluated on the basis of the clinical parameters will be recorded after 3- and 6-months and radiographic parameters will be recorded after 6 months.
 
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