| CTRI Number |
CTRI/2024/07/071752 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of the effect of immediate temporary crown on the maintenance of soft tissue profile and marginal bone level around immediately placed single implant |
|
Scientific Title of Study
|
Comparative evaluation of the effect of immediate provisionalization on the maintenance of soft tissue profile and marginal bone level around immediately placed single implant- Randomized controlled 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 |
Santhip vijay M |
| Designation |
Junior resident |
| Affiliation |
Government dental college, kozhikode |
| Address |
Room no 53, Department of Prosthodontics, 4th Floor,
Government dental college
no 54B, west street, SPK nagar, nallipalayam, namakkal
Kozhikode
KERALA
673008
India |
| Phone |
7397699155 |
| Fax |
|
| Email |
santhipvijay1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pramod kumar A V |
| Designation |
Head of the de[partment |
| Affiliation |
Government dental college, kozhikode |
| Address |
room no 53, 4th Floor, Department of Prosthodontics,
Government dental college, kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9447169055 |
| Fax |
|
| Email |
pramodav@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santhip vijay M |
| Designation |
Junior resident |
| Affiliation |
Government dental college, kozhikode |
| Address |
room no 53, 4th Floor, Department of Prosthodontics,
Government dental college, kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7397699155 |
| Fax |
|
| Email |
santhipvijay1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Santhip vijay M
room no 53, 4th Floor, Department of Prosthodontics,
Government dental college, kozhikode, kerala
673008, India |
|
|
Primary Sponsor
|
| Name |
Santhip vijay M |
| Address |
room no 53, 4th Floor, Department of Prosthodontics,
Government dental college, kozhikode, kerala- 673008, India |
| Type of Sponsor |
Other [principal investigator itself] |
|
|
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 Santhip vijay M |
Government dental college, kozhikode |
room no 53, 4th Floor, Department of Prosthodontics,
Government dental college, kozhikode kerala- 673008
Kozhikode
KERALA |
7397699155
santhipvijay1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college, kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy patients
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marginal bone levels, mid buccal mucosal level, mesial and distal interdental papilla, pink esthetic score |
The above mentioned parameters are examined in cases with immediately placed single dental implants in maxilla and mandible anterior teeth region with placing immediate provisionalization and final prosthesis will be placed after 3 months of implant placement |
| Comparator Agent |
Marginal bone levels, mid buccal mucosal level, mesial and distal interdental papilla, pink esthetic score |
The above mentioned parameters are examined in cases with immediately placed single dental implants in maxilla and mandible anterior teeth region without placing immediate provisionalization and final prosthesis will be placed after 3 months of implant placement. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of age group 20 to 60 years regardless of the gender.
2. Patients with single hopeless natural tooth in the anterior maxilla and anterior mandible due
to non-restorable caries, root resorption and traumatic injury without bone loss.
3. Adjacent natural tooth present with healthy periodontium.
4. Sufficient mesio-distal and apico-coronal space for an implant crown placement.
5. Healthy patients with absence of any systemic disease. |
|
| ExclusionCriteria |
| Details |
1. Patients developing systemic diseases during the study.
2. Patients failing to obtain osseo-integration after implant placement.
3. Patients who are pregnant or become pregnant during the course of the study.
4. Patients with uncontrolled periodontal disease, and poor oral hygiene.
5. Tooth to be replaced involved with severe periodontal bone loss |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marginal bone level around immediately placed implants
|
0,3 and 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mesial & distal interdental papilla height
mid- buccal mucosal height
Pink esthetic score |
0, 3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - santhipvijay1@gmail.com
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-0037?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Comparative evaluation of the effect of immediate provisionalization on the maintenance of soft tissue profile and marginal bone level around immediately placed single implant- Randomized controlled studyThis study investigates the marginal bone level and soft tissue profile around immediately placed dental implant with and without immediate provisionalization. The sample size of the study is 30 participants. the study period is 2 years . the outcomes are investigated at 3 stages For marginal bone level- At the time of implant placement, 3 month follow up and 9 month follow up For soft tissue profile- At the time of implant placement, 3 month follow up and 6 month follow up |