| CTRI Number |
CTRI/2022/06/043270 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
SOFT TISSUE CHANGES AND BONE LEVELS AROUND DENTAL IMPLANTS WITH LASER |
|
Scientific Title of Study
|
SOFT TISSUE CHANGES AND CRESTAL BONE LEVELS AROUND DENTAL IMPLANTS WITH LOW LEVEL LASER THERAPY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr YNR SUDESHNA TULABANDULA |
| Designation |
PG STUDENT |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8008013885 |
| Fax |
|
| Email |
tsudeshna13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAMANARAYANA BOYAPATI |
| Designation |
READER |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr YNR SUDESHNA TULABANDULA |
| Designation |
PG STUDENT |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8008013885 |
| Fax |
|
| Email |
tsudeshna13@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur |
|
|
Primary Sponsor
|
| Name |
Dr YNR SUDESHNA TULABANDULA |
| Address |
room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, 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 |
| Dr YNR SUDESHNA TULABANDULA |
sibar institute of dental sciences-guntur |
oom no 8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur room no.8, 2nd floor, department of periodontics, Sibar Institute of Dental Sciences, takellapaadu, guntur
Guntur
ANDHRA PRADESH |
8008013885
tsudeshna13@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: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dental implants without applying low level |
Implants sites will not be treated with low level laser.
|
| Intervention |
low level laser on dental implants |
Implants sites will be treated with low level laser at baseline, 7th day, 6 weeks and 3 months after implant placement.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals in need of tooth replacement.
2. Presence of adequate keratinized mucosa in the edentulous site.
3. Apparently healthy individuals.
4. Isolated mandibular edentulous sites with adequate bone quality and volume with D2 and D3 type of bone.
5. Individuals with age group of 20-60 years of either gender .
6. Patients who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Smokers
2. Individuals with parafunctional habits.
3. Pregnant and lactating women.
4. Systemic diseases that contraindicate implant placement and surgical procedure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the peri implant crestal bone levels and soft tissue changes with Low level laser therapy.
2. To evaluate the peri implant crestal bone levels and soft tissue changes without Low level laser therapy. |
baseline, 7th day, 6 weeks, 3 months and 6 months after implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the soft tissue changes and peri implant crestal bone levels with and without Low level laser therapy.
|
baseline, 7th day, 6 weeks, 3 months and 6 months after implant placement |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
17/06/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The procedure will be performed under local anesthesia using 2% lignocaine containing adrenaline 1:80,000. Implants will be placed by following surgical procedure in both the groups. After adequate local anesthesia, a mid-crestal incision is given in both the cases. A mucoperiosteal flap is elevated and bone will be exposed. Selected size of implants (3.5mm and 10mm) will be placed in group I and group II sites. The implant site will be prepared with standard drills. The osteotomy site is prepared with sequence of drills to the size of implant. Sites in group I will be treated with Low Level Laser and group II sites will not be treated with Low Level Laser. Flaps will be approximated and sutured. Instructions regarding oral hygiene maintenance and soft diet plan will be provided. Patient will be discharged after prescribing analgesics and antibiotic. Patient is recalled after 1 week for suture removal. Crown placement will be done after 3 months.clinical parameters like thickness of keratinized tissue, modified gingival index, modified plaque index, width of the keratinized tissue and crestal bone level (by IOPA radiographs) will be assessed at baseline, 3 months and 6 months. |