| 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
|
|
|
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
|
|
|
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 freezeâ€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 976â€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. |