| CTRI Number |
CTRI/2024/05/067064 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Socket Shield Technique versus Conventional Delayed Implant Placement |
|
Scientific Title of Study
|
Socket Shield Technique versus Conventional Delayed Implant Placement with Immediate Temporisation in Maxillary Premolar Region for evaluation of Clinical Outcomes: A Quasi-Experimental 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 |
Dr Shruti Potdukhe |
| Designation |
Lecturer |
| Affiliation |
MGM Dental college and hospital, Navi Mumbai |
| Address |
MGM Dental college and hospital, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096915009 |
| Fax |
|
| Email |
shrutispotdukhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Potdukhe |
| Designation |
Lecturer |
| Affiliation |
MGM Dental college and hospital, Navi Mumbai |
| Address |
MGM Dental college and hospital, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096915009 |
| Fax |
|
| Email |
shrutispotdukhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Potdukhe |
| Designation |
Lecturer |
| Affiliation |
MGM Dental college and hospital, Navi Mumbai |
| Address |
MGM Dental college and hospital, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096915009 |
| Fax |
|
| Email |
shrutispotdukhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental college and Hospital, Kamothe, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
MGM Dental College and Hospital |
| 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 Shruti Potdukhe |
MGM Dental college and Hospital |
MGM Dental college and Hospital, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA |
9096915009
shrutipotdukhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Missions Dental College and Hospital Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Implant Placement |
Conventional Delayed Implant Placement with Immediate Temporisation in Maxillary Premolar Region |
| Intervention |
Socket shield technique |
Socket Shield Technique with Immediate Temporisation in Maxillary Premolar Region |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Patients who are willing to participate in the study.
2. Patients of both the genders with age range of 20 to 65 years.
3. Nonrestorable maxillary premolar teeth.
4. Patient with healed edentulous maxillary premolar region
5. Fairly intact buccal periodontal tissues.
6. Any periodontal phenotype (thick or thin).
7. Patient with good oral hygiene.
8. No intraoral soft and hard tissue pathology
9. No systemic condition that contraindicate implant placement |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus
2. Patient with history of radiation therapy to the head and neck region.
3. Heavy smoker patients.
4. Teeth with periodontal disease.
5. Vertical root fracture
6. Horizontal fracture at or below the bone level
7. Teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 bone loss between implant
2 implant stability
3 pink esthetic score
4 patient satisfaction |
Baseline, 3 months, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 4 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-04-2024 and end date provided 01-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Aim: The present study aimed to compare the socket shield technique with immediate temporization vs the conventional delayed implant placement with immediate temporization in the maxillary premolar region. The primary outcome is the assessment of the horizontal and vertical dimensional changes of the labial plate of bone, implant stability, pink esthetic score (PES) evaluation, and patient satisfaction. Research Question: Is there a difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implants placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region? Primary Hypothesis: There is no difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implant placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region. Alternate Hypothesis: There is a difference in the amount of bone loss, implant stability, pink esthetic score and patient satisfaction between implants placed using the socket shield technique with immediate temporisation and conventional delayed implant placement with immediate temporisation in the maxillary premolar region. Clinical Significance: It will help the clinician to decide whether the remaining natural root can be preserved; to prevent the natural process of bone resorption; and will give a choice of Immediate implant placement and prosthetic rehabilitation.
|