| CTRI Number |
CTRI/2025/01/079330 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION OF PERI IMPLANT SOFT AND HARD TISSUE DIMENSIONAL CHANGES IN IMMEDIATE IMPLANT PLACEMENT WITH TOOTH GRAFT A CLINICAL AND RADIOGRAPHIC STUDY
|
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Scientific Title of Study
|
EVALUATION OF PERI IMPLANT SOFT AND HARD TISSUE DIMENSIONAL CHANGES IN IMMEDIATE IMPLANT PLACEMENT WITH AUTOGENOUS DENTIN GRAFT A CLINICAL AND RADIOGRAPHIC STUDY
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALFAS RASI MP |
| Designation |
PG student |
| Affiliation |
Government dental college Indore |
| Address |
ROOM NUMBER 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE M Y HOSPITAL SARDER PATEL MARG INDORE
Indore
MADHYA PRADESH
452001
India |
| Phone |
09544100500 |
| Fax |
|
| Email |
alfasrasimp123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MADHU S RATRE |
| Designation |
Proffesor & HOD |
| Affiliation |
Government college of dentistry, Indore |
| Address |
ROOM NUMBER 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE M Y HOSPITAL SARDER PATEL MARG INDORE
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
Smadhu16Feb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR MADHU S RATRE |
| Designation |
Proffesor & HOD |
| Affiliation |
Government college of dentistry, Indore |
| Address |
ROOM NUMBER 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE M Y HOSPITAL SARDER PATEL MARG INDORE
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
Smadhu16Feb@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GOVERNMENT COLLEGE OF DENTISTRY INDORE |
| Address |
ROOM NUMBER 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE M Y HOSPITAL SARDER PATEL MARG INDORE
|
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alfas Rasi Mp |
Government College of Dentistry INDORE |
Room number 10, Department of Periodontology, Government College of Dentistry INDORE
Indore
MADHYA PRADESH |
9544100500
alfasrasimp123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry,Indore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jumping gap around immediate implant 2mm. |
a. Hard tissue parameter:1. Peri implant crestal bone level 2. Jumping distance. b. Soft tissues parameters: soft tissue thickness around implant (Th), Peri-implant Probing depth (PiPD), and position of peri implant soft tissue. clinically and radiographically within time period of T0,T1,T2,T3. A) Base line -At immediate post implant placement (T0) B) 3 months after implant placement (T1). C) At the time of implant loading(T2) D) 3 months after implant loading (T3) |
| Intervention |
Jumping gap around immediate implant less than 2mm |
a. Hard tissue parameter:1. Peri implant crestal bone level 2. Jumping distance.
b. Soft tissues parameters:soft tissue thickness around implant (Th), Peri-implant Probing depth (PiPD), and position of peri implant soft tissue.s clinically and radiographically within time period of T0,T1,T2,T3. A) Base line -At immediate post implant placement (T0) B) 3 months after implant placement (T1). C) At the time of implant loading(T2) D) 3 months after implant loading (T3)
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
(1)Age:20 to 50 years male /female and able to sign an informed consent form.
(2) Periodontal sound single rooted tooth that indicated for extraction due to trauma, root caries, iatrogenic errors.
(3) Presence of adequate and harmonious gingival architecture with the surrounding dentition.
(4) Who will be ready to have their progress followed for at least 6months.
(5) Maintainable oral hygiene |
|
| ExclusionCriteria |
| Details |
(1) Patient requiring extraction of root canal treated teeth and teeth with periapical pathology.
(2) Extraction sites with a partial or complete deficiency of buccal bone plate.
(3) History of allergy or systemic diseases such as diabetic mellitus , hypertension ,immunocompromising diseases, etc.
(4) Patient with systemic medication like Long-term steroidal and/or aminobisphosphonate therapy.
(5) Presence of active periodontal disease.
(6) Smokers and/ or consuming tobacco in any form.
(7) Acute infection in the failing tooth.
(8) Unwillingness to return for the follow-up examination |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to analyse peri implant alveolar bone dimensional changes in vertical and horizontal direction after immediate implant placement with autogenous dentin graft in jumping gap less than or equal to 2mm(group 1) and more than 2mm (group 2) |
base line and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the soft tissue thickness, position, and width of keratinized tissue around implant in both cases after intervention |
after 6 months |
|
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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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Immediate implant has the advantage of simplifying the clinical procedures and reducing the overall treatment time and one of the main challenges while placing the implant immediately in the socket is the jumping distance that is present in the area surrounding the coronal portion of the implant and socket wall and the space should be filled with any graft material |