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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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