| CTRI Number |
CTRI/2020/02/023547 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
13/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Light and Certain Wire Fixing Technique of Tooth with Injury for better Wound Healing and Maintaining Tooth long life. |
|
Scientific Title of Study
|
Evaluation of photo-biomodulation for periodontal healing and preservation of tooth vitality in luxation injuries of immature permanent incisors - A preliminary study |
| Trial Acronym |
LASER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Chaurasia |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
South
DELHI
110029
India |
| Phone |
09878950126 |
| Fax |
|
| Email |
drbikashaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Tewari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
South
DELHI
110029
India |
| Phone |
9839311058 |
| Fax |
|
| Email |
dr.nitesht@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Chaurasia |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
Centre For Dental Education And Research(CDER)
AIIMS
NEW DELHI
Division Of Pedodontics And Preventive Dentistry
South
DELHI
110029
India |
| Phone |
09878950126 |
| Fax |
|
| Email |
drbikashaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CDER |
| Address |
CDER,AIIMS,New Delhi,6th floor
Dept.of Pedodontics and Preventive Dentistry,Ansari Nagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrBikash Chaurasia |
All India Institute Of Medical Sciences,New Delhi |
Centre for Dental Education and Research(CDER),AIIMS,NEW DELHI
6th floor,Dept.of Pedodontics and Preventive Dentistry
South
DELHI |
09878950126
drbikashaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T799||Unspecified early complication oftrauma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photobiomodulation |
Photobiomodulation on day 0,day 1 and day 2 along with physiologic splinting and subsequent follow-ups for 2 weeks,1 months,3 months,6 months and 12 months |
| Comparator Agent |
Physiologic splinting only |
Physiologic splinting with wire and composite splint and subsequent follow-ups for 2 weeks,1 months,3 months,6 months and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1) Immature permanent incisors with subluxation injuries or lateral luxation with/without
uncomplicated crown fractures.
2) Patients reporting on the same day or within 24 hours of Traumatic Dental Injury.
3) Patients giving assent and parents consenting to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Traumatic dental injuries other than lateral luxation and subluxation such as complicated
crown fracture, crown root fracture, root fracture, dentoalveolar fracture, concussion,
intrusive luxation, extrusive luxation and tooth avulsion.
2) Associated maxillofacial trauma in the region.
3) Combination trauma indicated for endodontic management.
4) Patients suffering from any chronic systemic diseases or on long term medications.
5) Teeth with dental caries (any signs and symptoms of pulpitis).
6) Teeth with signs of loss of tooth vitality (like discoloration, non-tender on percussion,
absence of pain, no response to pulp testing).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Soft Tissues and maintenance of Tooth Vitality |
2 weeks
1 months
3 months
6 months
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Healing
Gingival Health
Mobility of Tooth
Radiographic Changes |
2 weeks
1 months
3 months
6 months
12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this preliminary study is to determine the effect of photo-biomodulation for periodontal healing and preservation of tooth vitality in luxation injuries of immature permanent incisors.
Photo-biomodulation used along-with splinting protocol (IADT 2012) in immature permanent incisors with luxation injuries during initial phase will lead to better periodontal healing and preserve the vitality of the tooth during the study period, in comparison to the injured teeth managed by splinting protocol (IADT 2012) alone. Hence, we hypothesized that photo-biomodulation using 940nm nm diode laser can improve healing and preserve tooth vitality in subluxation and lateral luxation of immature permanent incisors.
|