| CTRI Number |
CTRI/2016/06/007013 [Registered on: 10/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
10/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of cleaning of teeth alone or cleaning of teeth along with lasers during maintenance of gum health. |
|
Scientific Title of Study
|
DIODE LASER AS AN ADJUNCTIVE TO NON SURGICAL PERIODONTAL THERAPY DURING MAINTENANCE PHASE: A RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUPRITH SS |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM college of dental sciences and hospital |
| Address |
KUMAR HOSTEL SDM College of Dental Sciences and Hospital
Sattur Dharwad
KUMAR HOSTEL SDM College of Dental Sciences and Hospital
Sattur Dharwad
Dharwad
KARNATAKA
580 009
India |
| Phone |
09538950366 |
| Fax |
|
| Email |
suprith90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SWATI SETTY |
| Designation |
PROFESSOR DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY |
| Affiliation |
SDM college of dental sciences and hospital |
| Address |
DR SWATI SETTY
MDS
PROFESSOR
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
09845680773 |
| Fax |
|
| Email |
drssetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SWATI SETTY |
| Designation |
PROFESSOR DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY |
| Affiliation |
SDM college of dental sciences and hospital |
| Address |
DR SWATI SETTY
MDS
PROFESSOR
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL
DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
09845680773 |
| Fax |
|
| Email |
drssetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF DENTAL SCIENCES AND HOSPITAL SATTUR DHARWAD |
|
|
Primary Sponsor
|
| Name |
DR SUPRITH |
| Address |
DR SUPRITH SS
POST GRADUATE STUDENT
DEPT OF PERIODONTICS AND ORAL IMPLANTOLOGY WARD 7
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL
SATTUR DHARWAD KARNATAKA
|
| 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 SUPRITH SS |
SDM COLLEGE OF DENTAL SCIENCE |
WARD 7 DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY
SDM COLLEGE OF DENTAL SCIENCES AND HOSPITAL
SATTUR DHARWAD KARNATAKA
Dharwad
KARNATAKA |
09538950366
suprith90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CHRONIC PERIODONTITIS , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SCALING AND ROOT PLANING |
Scaling and root planing using a piezoelectric ultrasonic unit at a moderate setting and with the appropriate tips was performed and time spent in Scaling and root planing on each tooth was not restricted. |
| Comparator Agent |
SCALING AND ROOT PLANING ALONG WITH DIODE LASER |
Scaling and root planing using a piezoelectric ultrasonic unit at a moderate setting and with the appropriate tips was performed and time spent in scaling and root planing on each tooth was not restricted.
Gallium-Aluminium-Arsenide diode laser with a wavelength of 940 nm set at a power output of 2 W average power 0.66 W in pulse interval of 20ms and pulse length of 20ms delivering 30 s/cm 2 and 15 J/cm 2 of energy was used. Irradiation was accomplished using a 300 µm fiber optical delivery system which was moved from the coronal to the apical side of the interdental pockets. It was done from mesially to distally in buccal pockets and from distally to mesially in lingual/palatal pockets. Sweeping motion was used for every pocket in parallel paths with an inclination of approximately 20°towards gingival wall reaching a total of 30 seconds for each tooth. Each pocket was lased for 30 sec twice, with a 60 sec interval at baseline and 7 days. The fiber tip was regularly inspected and cleaned with damp sterile gauze to remove buildup of soft tissue debris on the tip. All the laser safety measures were followed. The periodontal pocket was irrigated with normal saline after each session of irradiation. In order to have standardization pockets treated with scaling and root planing alone were also irrigated. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult periodontal maintenance patient with a history of treatment for chronic periodontitis who had received no active or maintenance periodontal therapy at least 6-months prior to the study
2. Systemically healthy subjects
3. Subjects aged from 25 years to 60years,
4. One or more periodontal sites with pocket depth more than or equal to 4 mm
5. Relative attachment level more than or equal to 3 mm
6. Bleeding on probing and subjects who were compliant with terms of study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Lactating mothers
3. Smokers
4. Use of antibiotics and analgesics within six months prior to study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE CLINICAL PARAMETERS WHICH ARE PROBING POCKET DEPTH RELATIVE ATTACHMENT LEVEL PLAQUE INDEX AND BLEEDING ON PROBING BEFORE AND AFTER THE ALLOCATED THERAPY WITH IN THE GROUP AND BETWEEN THE GROUPS |
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE PAIN INVOLVED IN BOTH THE THERAPIES |
IMMEDIATELY AFTER THERAPY |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A variety of non-surgical and surgical therapies are used to treat chronic periodontitis. Limitations in conventional non-surgical periodontal therapy have led to the exploration of other treatment options to improve clinical outcomes. Lasers have been proposed as alternative treatment for non-surgical periodontal therapy and are patient friendly. There are few studies reporting laser use in maintenance phase. To determine and compare the pocket depths, relative attachment levels, bleeding on probing and plaque indices in patients treated with scaling and root planing alone and along with diode laser.The study is carried out on 30 subjects who full fill the inclusion and exclusion criteria Group A: 15 patients treated only with scaling and root planing . Group B: 15 patients treated with scaling and root planing along with diode laser irradiation. The clinical parameters are probing pocket depth, relative attachment level, bleeding on probing and plaque index which were recorded at base line, 7 days and after 1 month. And results showed that the use of diode lasers as an adjunct to scaling and root planing during maintenance phase showed better results when compared to scaling and root planing alone. Moderate periodontal pockets with moderate attachment loss showed significant improvement in Group A than in Group B. There was no change in deep pockets with severe attachment loss in both groups. |