| CTRI Number |
CTRI/2025/05/087444 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of provisional restoration on modified pink esthetic score fabricated by two methods CAD CAM and conventional in immediate implant placement |
|
Scientific Title of Study
|
Comparative evaluation of effect of CAD CAM provisional restoration and chairside provisional restoration on modified pink esthetic score in immediate implant placement an in vivo 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 |
Prajakta Humane |
| Designation |
Second year post graduate student |
| Affiliation |
Government Dental college Raipur |
| Address |
Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
7276603235 |
| Fax |
|
| Email |
prajakta90.humane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepesh Kumar Gupta |
| Designation |
Head of the Department |
| Affiliation |
Government Dental College Raipur. |
| Address |
Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
7276603235 |
| Fax |
|
| Email |
dr_deepesh25@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prajakta Humane |
| Designation |
Second year post graduate student |
| Affiliation |
Government Dental College Raipur |
| Address |
Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur Chhattisgarh 492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
7276603235 |
| Fax |
|
| Email |
prajakta90.humane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur Chhattisgarh 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Humane |
| Address |
Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur Chhattisgarh 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 Prajakta Humane |
Government Dental College Raipur |
Room no 3 Department of Oral and Maxillofacial Prosthodontics and Implantology
Raipur
CHHATTISGARH |
7276603235
prajakta90.humane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Human studies Government Dental College Raipur Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD CAM provisional restoration |
After the placement of immediate implant a provisional crown is fabricated using CAD CAM dental designer software using temporary crown material. Post surgical assessment will be done with intraoral photographs and modPink esthetic score will be assessed at 4 months before removal of provisional crown fabricated with CAD CAM technique and after 2 months of placement of permanent restoration. |
| Comparator Agent |
Chairside provisional restoration |
After the placement of immediate implant a provisional crown is fabricated by Chairside technique using temporary crown material. Post surgical assessment will be done with intraoral photographs and modPink esthetic score will be assessed at 4 months before removal of provisional crown fabricated with chairside technique also after 2 months of placement of permanent restoration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age more than 18years
Failed root canal treated cases
Fractured crowns and roots
Systemically healthy subjects with no absolute contraindication to implant
Able to achieve good oral hygiene
Patient with good gingival and periodontal health
Patient willing to undergo surgical procedure
Adequate native bone volume quality and quantity
Opposing dentition with natural or prosthetic teeth |
|
| ExclusionCriteria |
| Details |
Inability to accept or cooperate implant treatment
Presence of periapical lesion greater than 2mm
Patient who is undergoing and recent history of radiation therapy
Uncontrolled systemic disease like diabetes hypertension
Inadequate oral hygiene or persistent intra oral infection
Patient with habit of smoking of more than 10 cigarettes per day
Presence of benign and malignant tumor
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Researcher will come to know if there is any effect on modPink Esthetic Score in immediate implant cases by using two different provisional restoration CAD CAM with chairside provisional restoration at 0, 4, 6 months |
Researcher will come to know if there is any effect on modPink Esthetic Score in immediate implant cases by using two different provisional restoration CAD CAM with chairside provisional restoration after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Researcher findings may help operator in making clinical decision about most suitable provisionalization technique in immediate implant cases which will enhance clinical practice. |
at 0,4,6 months |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
01/06/2025 |
| 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="11"
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
|
|
Brief Summary
|
Patient will be given informed consent and undergo preoperative investigations. After Immediate implant placement patient will be given provisional restoration fabricated with CAD CAM and chairside technique group as A and B respectively. Post surgical assessment will be done to compare mod Pink esthetic score at 0 4 6 months using intraoral photographs by two examiners. |