| CTRI Number |
CTRI/2021/03/032402 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to evaluate the effect of light therapy using blue light emitting diode in comparison with low level laser around healing dental implants. |
|
Scientific Title of Study
|
A randomized clinical study to evaluate the effect of Photobiomodulation therapy using blue light emitting diode in comparison with low level laser on hard and soft tissue healing around dental implants. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aaditee Vande |
| Designation |
PhD scholar |
| Affiliation |
Department of Prosthodontics, SDS, KIMSDU |
| Address |
School of Dental Sciences, KIMSDU
School of Dental Sciences, KIMSDU
Satara
MAHARASHTRA
415110
India |
| Phone |
|
| Fax |
|
| Email |
v.aaditee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pronob Sanyal |
| Designation |
Prof and Head |
| Affiliation |
Department of Prosthodontics, SDS, KIMSDU |
| Address |
School of Dental Sciences, KIMSDU
School of Dental Sciences, KIMSDU
Satara
MAHARASHTRA
415110
India |
| Phone |
|
| Fax |
|
| Email |
sanyalpronob@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aaditee Vande |
| Designation |
PhD scholar |
| Affiliation |
Department of Prosthodontics, SDS, KIMSDU |
| Address |
School of Dental Sciences, KIMSDU
School of Dental Sciences, KIMSDU
Satara
MAHARASHTRA
415110
India |
| Phone |
|
| Fax |
|
| Email |
v.aaditee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of Medical Sciences |
| Address |
Krishna Institute of Medical Sciences, Karad. 415539 |
| 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 |
| dr aaditee vande |
School of Dental Sciences |
department no 12, 1st floor, School of Dental Sciences, KIMSDU
Satara
MAHARASHTRA |
8806767743
v.aaditee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
single missing maxillary or mandibular tooth |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
blue light emitting diode |
The light used in the study will be light emitting diode of 800 Mw/cm2 and 430-490 nm wavelength. (Ivoclar Vivadent Bluephase N MC light)
Intraorally the LED probe will be applied for 45 seconds each in the vestibular and lingual area (approximately 1 cm away from the tissues) at the operated site.
The procedure will be carried out immediately after surgery, 7th and 14th post-operative day
|
| Intervention |
Low Level Laser Therapy |
The laser used in the study will be diode laser of 10 Watts intensity and 980 nm wavelength (Zolar Tech Mfg Co. Inc, Mississauga, Canada). Energy will be 4 J on each side of implant totalling to 8 J per session. Intraorally the laser probe will be applied for 40 seconds each in the vestibular and lingual area (approximately 1 cm away from the tissues) at the operated site. The procedure will be carried out immediately after surgery, 7th and 14th post-operative day.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females requiring replacement of single missing tooth with dental implant.
2. Patients age between 20-45 years.
3. Those who will provide informed consent.
4. Extraction done at least 2 months prior to implant placement.
5. Patients not requiring bone augmentation procedures.
|
|
| ExclusionCriteria |
| Details |
History of
1. leukocyte dysfunction or deficiencies
2. bleeding disorders
3. neoplastic disease requiring radiation or chemotherapy
4. metabolic bone disorder
5. uncontrolled endocrine disorders
6. HIV infection
7. uncontrolled diabetes
8. patients on immunosuppressive therapy.
9. Alcoholism or drug abuse or heavy smokers and tobacco chewers.
10. History of aggressive periodontitis.
11. Irradiation history
12. Unhealed extraction socket
13. Pregnant women
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary stability of dental implant |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bone density around dental implant |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental implants are the most modern way to replace missing teeth
with high success rate. Bone formation at the bone-implant interface
is critical factor in implant success. Photobiomodulation therapy
has been applied in various clinical situations and has become an attractive
alternative to enhance wound healing and bone formation. It involves the
application of a monochromatic light with a low energy density which induces
non thermal photochemistry effects on cellular level. But there are very few
clinical studies evaluating its effect on hard and soft tissue around dental
implants. Also laser equipment being expensive, is not readily available in all
dental setups. An alternative cheaper option could be the use of routine dental
curing light (blue LED).The present study aims at evaluating the effect of Blue
LED and LLLT on the hard and soft tissue around dental implants. The study will
involve 3 groups; control group (no therapy), study group 1 (LLLT) and study
group 2 (blue LED therapy). The parameters that will be evaluated are primary
and secondary stability of implants, bone density and soft tissue healing
around dental implants at different time intervals. The results will be
statistically analysed to evaluate the outcome. |