| CTRI Number |
CTRI/2018/05/014283 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing the effectiveness of treatment of oral leukoplakia with dry ice and lasers |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF CRYOSURGERY AND LASER THERAPY IN THE TREATMENT OF ORAL LEUKOPLAKIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K N V Sai Praveen |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology Room No 1 Block No 3
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9849039236 |
| Fax |
|
| Email |
sp.kotubds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sudhakara Reddy |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology Room No 1 Block No 3
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848599049 |
| Fax |
|
| Email |
sudhakarareddyomr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sudhakara Reddy |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral Medicine and Radiology Room No 1 Block No 3
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9848599049 |
| Fax |
|
| Email |
sudhakarareddyomr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr K N V Sai Praveen |
| Address |
Department of Oral Medicine and Radiology Room No 1 Block No 3
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
|
| 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 |
| Dr K N V Sai Praveen |
Vishnu Dental College |
Department of Oral Medicine and Radiology Room No 1 Block No 3
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
West Godavari
ANDHRA PRADESH |
9849039236
sp.kotubds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Oral Leukoplakia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cryosurgery |
cryosurgery for oral leukoplakia |
| Intervention |
laser therapy |
laser therapy for oral leukoplakia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age above 20 years.
2. Lesions greater than 1 cm in diameter.
3. Patients willing to cease tobacco and alcohol habits. |
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with systemic diseases that can interfere with healing. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of the lesion |
Healing of the lesion using Wound healing assessment score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comfortability of the patient after the treatment
Recurrence of the lesion |
Comfortability of the patient after the treatment using VAS score
Recurrence of the lesion seen for 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/03/2014 |
| Date of Study Completion (India) |
18/08/2015 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main aim of the present longitudinal comparative clinical study was to clinically evaluate the effectiveness of laser therapy and cryosurgery in the management of OL.
A total of 30 subjects were included in the present study and were randomly allocated into two groups i.e., either cryo group wherein subjects were treated with cryotherapy or Laser group in which 810nm diode Laser was used for therapy. Patients were recalled for periodic review and check up at an interval of 1st, 2nd, 3rd week, 2nd and 3rd month respectively. 10cm VAS scale was used for evaluating the postoperative discomfort due to pain and Bates- Jensen Wound Assessment Tool was used to evaluate clinical wound healing. All the parameters were recorded in a specially designed proforma. Later the data was subjected to statistical analysis.
Data analysis was done by using ONE WAY ANOVA for intra group variations and POST HOC TUKEY TEST for observing in depth difference between each time interval of same group. For inter group comparisons Paired t test was used.
In the present study Bates-Jensen wound assessment tool with 13 components was used for assessment of clinical healing at operated site. To the best of the knowledge as evidenced in the existing scientific literature, the present study is first of its kind where all the parameters of healing were assessed and analysed.
When post-operative pain was observed, it reduced by the end of 3rd week in both the groups. Healing was comparatively faster in cryo group than in Laser group. But significant number of recurrences was noticed in subjects of cryo group.
In conclusion, though the results suggest that both cryosurgery and Laser therapy were effective in terms of patient comfort, owing to the number of recurrent cases recorded in the cryo group and also mild elevated post-operative edema make cryotherapy a little cumbersome to the patient. On the other hand not much recurrence and post-operative complications were observed in laser group. This suggests that Laser therapy is advantageous over cryosurgery.
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