Comparison of Marginal Fit and Internal Adaptation in All... | NCT06067945

Studies
Comparison of Marginal Fit and Internal Adaptation in All-Metal Crowns: an in Vitro Experimental Trial

NCT06067945

Sponsor

Altamash Institute of Dental Medicine

Status

Recruiting

Last Update Posted

Feb 26, 2025Actual

Enrollment

28Estimated

Phase

Not provided

Conditions

Evaluation of Marginal and Internal Fit of Metal Crowns

Interventions

microleakage

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2025Actual

Primary Completion Date

Jun 20, 2025Estimated

Completion Date

Jun 20, 2025Estimated

First Submitted Date

Sep 25, 2023

First Submission Date that Met QC Criteria

Oct 3, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tooba Shabbir, Post Graduate Trainee, Altamash Institute of Dental MedicinePrincipal Investigator

Lead Sponsor

Altamash Institute of Dental MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this in vitro study is to compare the marginal fit and internal adaptation of all-metal crowns in polished crown preparations and non-polished crown preparations The main question it aims to answer is: are the non polished tooth preparations comparable to polished preparations? We will compare polish and non polish groups and see their effects on marginal fit and internal adaptation of all metal crown

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NP is given to the non polished group which is group 2		Out of two groups, group 2 is a test group to which rough preparations are assigned	Other: microleakage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microleakage	Other	prevention of microleakage and secondary carries	NP is given to the non polished group which is group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
marginal fit	The margins of fixed restorations refers to the junction between the prepared tooth structure and the crown restoration	six months

Secondary Outcomes

Measure	Description	Time Frame
Internal fit	Internal fit is defined as the perpendicular distance between the framework and abutment teeth and the misfit is measured from occlusal/incisal and axial surfaces to the coping	six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Phantom teeth
Maxillary molars
Metal crowns with conventional lost-wax technique for crown fabrication

Exclusion Criteria:

Over prepared or underprepared crowns
Defective metal crowns
Ruptured silicone films upon removal
Defective die stone casts

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The phantom teeth (Nissin dental products Inc. Kyoto 601-8469,Japan) will be fixed in the model plaster block type II (Super national, Karachi Pakistan) with full crown and only 2mm of root portion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tooba Shabbir, FCPS	Contact	03442105654		tooba.shabbir92@gmai.com

Overall Officials

Name	Affiliation	Role
Naseer Ahmad, Ph.D	Altamash Institute of Dental Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altamash Institute Of Dental Medicine	Recruiting	Karachi	Sindh	5444	Pakistan