| CTRI Number |
CTRI/2024/12/078121 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To determine the effect of two different sterilization techniques on level of absolute sterility of healing abutments. |
|
Scientific Title of Study
|
Effect of two sterilization techniques on absolute sterility of healing abutments. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambika Thakur |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College Rajbandha Maidan path Raipur Chhattisgarh |
| Address |
Department of Prosthodontics, Room Number 3
Government Dental College Rajbandha Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8839281558 |
| Fax |
|
| Email |
ambikathakur1000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepesh Kumar Gupta |
| Designation |
PROF & HOD |
| Affiliation |
Government Dental College Rajbandah Maidan path Raipur Chhattisgarh |
| Address |
Government Dental College Rajbandah Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8966910000 |
| Fax |
|
| Email |
dr_deepesh25@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambika Thakur |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental College Rajbandah Maidan path Raipur Chhattisgarh |
| Address |
Department of Prosthodontics,
Government Dental College Rajbandah Maidan path Raipur Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8839281558 |
| Fax |
|
| Email |
ambikathakur1000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Rajmandha Maidan path Raipur Chattisgarh India 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Ambika Thakur |
| Address |
Room no. 219
Girls hostel government dental college Rajbandha maidan path Raipur Chhatttisgarh India 492001 |
| 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 Ambika Thakur |
Government Dental College Raipur |
Room Number 3 Department of Oral and Maxillofacial Prosthodontics & implantology rajbandha maidan path Raipur chhattisgarh
Raipur
CHHATTISGARH |
8839281558
ambikathakur1000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college raipur(c.g) institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
dental implant healing abutment sterilization |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% sodium hypochloride
70% ethyl alcohol |
2ml solution per healing abutment |
| Comparator Agent |
phloxin B stain |
After the healing abutment is cleaned with the solution that is sodium hypoclorite and ethyl alcohol, the healing abutments will be placed in an eppendorff tube containing 2 ml of phloxine B solution for 2 minutes for staining. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age ≥18 years.
2. Patients in which implants has been placed.
3.Patients in which two stage implant surgery is going to be done after three months of implant placement.
4. Retrieved healing abutments after 2nd stage surgery.
5. Systemically healthy subjects with no absolute contraindication to implant surgery.
6. Able to achieve good oral hygiene.
7. Patient with good gingival and periodontal health
|
|
| ExclusionCriteria |
| Details |
Patient who is undergoing and recent history of radiation therapy.
2.Uncontrolled systemic diseases like diabetes, hypertension etc.
3.Pregnant and lactating mother.
4.Inadequate oral hygiene or persistent intra oral infection.
5. Patient should not suffer from salivary gland diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Researcher will come to know the effect of different methods of sterilization on the biological environment of healing abutments. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient who is undergoing & recent history of radiation therapy.
2.Uncontrolled systemic diseases like diabetes, hypertension etc.
3.Pregnant & lactating mother.
4.Inadequate oral hygiene or persistent intra oral infection.
5. Patient should not suffer from salivary gland diseases
|
baseline |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| Date of Study Completion (India) |
10/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RETIEVAL OF HEALING ABUTMENTS Patients in which implants and healing abutments has been placed are selected for the study. After the second stage surgery, healing abutments will be retrieved from different participants. All HAs will be examined for factors such as visible deformation on the abutment surface (e.g., scratches or colour changes), visible residual contamination (e.g., calculus or food debris).
STERLIZATION PROCEDURE AND TESTING The sterilization process began with a pre-cleaning procedure to remove the macroscopic debris, these were initially inspected with unaided vision to determine if any debris or other damage or contamination could be detected and removed by brush, followed by an immersion of abutments in high biocidal disinfectant. In first group healing abutments will be immersed in sodium hypochlorite solution and in the second group healing abutments will be immersed in 70% ethyl alcohol.
|