| CTRI Number |
CTRI/2020/11/028963 [Registered on: 06/11/2020] Trial Registered Prospectively |
| Last Modified On: |
04/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between implants without any coating and the implants coated with blood products when placed in well-controlled diabetic patients which are checked upto 1 year. |
|
Scientific Title of Study
|
Comparative evaluation of conventional implants and i-PRF coated implants placed in well-controlled diabetics: A 1 year follow-up. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor, Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Room no. 7, block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor, Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Room no. 7, block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Inti Srividya |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no. 7, block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7892516537 |
| Fax |
|
| Email |
sri.vidya3895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 7
Block 2
Vishnu Dental college
Bhimavaram
West Godavari District
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Inti Srividya |
| Address |
Room no. 7, block 2, Department of Periodontics and Implantology, Vishnu Dental College, Vishnupur, Bhimavaram,West Godavari district, Andhra Pradesh. pin code: 534202. |
| Type of Sponsor |
Other [Vishnu Dental college] |
|
|
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 |
| Inti Srividya |
Vishnu Dental College |
Room no:7, Block 2,
Department of
Periodontics and
Implantology, Vishnu
Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH |
7892516537
sri.vidya3895@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: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional implants |
non-coated titanium
4.2 mm width
10 mm length
in lower back tooth region of well-controlled diabetic patients. |
| Comparator Agent |
i-PRF coated implants
|
implants coated with injectable-Platelet Rich Fibrin
4.2 mm width
10 mm length in lower back tooth region of well-controlled diabetic patients |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with missing teeth in back teeth region in the lower jaw.
well-controlled diabetic patients under medication.
patients who are capable of undergoing conventional implant surgery
patients willing to comply with the study requirements. |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetic patients who are not under medication.
Patients with poor oral hygiene.
Patients with severe night grinding habbit.
Pregnant women.
Lactating women.
Smokers and alcohol abusers.
Patients with a history of radiotherapy to head and neck.
Active infection at intended implant sites. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Implant Stability Quotient. Crestal bone loss using CBCT.
|
baseline, 3 months, 6 months, 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| torque insertion using torque ratchet |
baseline
3 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A sample size of 10 patients having 2 teeth missing in lower back teeth region will be selected. Written informed consent will be obtained from the patients.HBA1c values will also be checked on the day of 1st appointment. Values are preferred to be less than 8%. i-PRF will be prepared in the department after collecting 10 ml of blood from the patient.Non- coated conventional implants will be placed in the region of one missing tooth and i-PRF coated implants will be placed in the region of another missing tooth. Implant stability and bone loss around implant will be compared between these two implants placed in the same individual .HBA1c values will be followed up for 1 year. Implant stability and bone level around implants will be checked on the day of 1st appointment, at 3 months, at 6 months and 1 year. |