CTRI Number |
CTRI/2022/06/043193 [Registered on: 13/06/2022] Trial Registered Prospectively |
Last Modified On: |
02/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Evaluation of soft tissue and bone height changes around calcium-phosphate coated and uncoated implants |
Scientific Title of Study
|
Evaluation of soft and hard tissue changes with and without calcium-phosphate coated implants |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kota Sindhu |
Designation |
PG Student |
Affiliation |
Sibar Institute of Dental Sciences |
Address |
Room no 8,Department of Periodontics,Floor no 2,Sibar Institute of Dental Sciences,Takkelapadu,Guntur
Guntur ANDHRA PRADESH 522509 India |
Phone |
9866889394 |
Fax |
|
Email |
kotasindhu1718@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr D Ravindranath |
Designation |
Professor and Head of the department |
Affiliation |
Sibar Institute of Dental Sciences |
Address |
Room no 8,Department of Periodontics,Floor no 2,Sibar Institute of Dental Sciences,Takkelapadu,Guntur
Guntur ANDHRA PRADESH 522509 India |
Phone |
9849222259 |
Fax |
|
Email |
ravident69@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kota Sindhu |
Designation |
PG Student |
Affiliation |
Sibar Institute of Dental Sciences |
Address |
Room no 8,Department of Periodontics,Floor no 2,Sibar Institute of Dental Sciences,Takkelapadu,Guntur
Guntur ANDHRA PRADESH 522509 India |
Phone |
9866889394 |
Fax |
|
Email |
kotasindhu1718@gmail.com |
|
Source of Monetary or Material Support
|
SIBAR Institute of Dental Sciences |
|
Primary Sponsor
|
Name |
kota sindhu |
Address |
Room no:8,Second floor,Department of Periodontics,Sibar Institute of Dental Sciences,Takkellapadu,Guntur,Andhra Pradesh-522509 |
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 |
Kota Sindhu |
Sibar Institute of Dental Sciences |
Room no:8,Floor no:2,Department of Periodontics,Sibar Institute of Dental Sciences,Takkellapadu,Guntur,Andhra Pradesh-522509 Guntur ANDHRA PRADESH |
9866889394
kotasindhu1718@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics comittee |
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 |
Intervention |
Calcium-Phosphate coated implants |
Calcium-Phosphate coated implants will be placed in edentulous sites in test group patients for 30 to 40 minutes. |
Comparator Agent |
Dental Implants without Calcium-Phosphate coating |
Dental Implants without Calcium-Phosphate coating will be placed in edentulous sites in control group patients. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Individuals with age group of 20-60 years.2.Apparently healthy individuals. 3.Individuals in need of tooth replacement.
4.Isolated mandibular edentulous sites with adequate bone quality (D2 or D3 type) and volume.
5.Presence of adequate keratinized tissue at the edentulous site.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 soft tissue and crestal bone levels around calcium-phosphate coated implants.
2.To evaluate soft tissue and crestal bone levels around uncoated implants.
|
baseline,3months,6months |
|
Secondary Outcome
|
Outcome |
TimePoints |
3.To compare soft tissue and crestal bone levels between calcium-phosphate coated and uncoated implants. |
baseline,3months,6months |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/06/2022 |
Date of Study Completion (India) |
18/01/2024 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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. 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 placement of calcium-phosphate coated implants and sites in group II will be treated with placement of uncoated implants. After placement, stability is checked by RFA at baseline. Cover screw will be given following the implant placement in both groups. 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 antibiotics.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 plaque index,width of keratinized tissue and crestal bone level(by IOPA radiographs) will be assessed at baseline,3 months and 6 months. |