Healing Abutment Materials on Matrix Metalloproteinase-8... | NCT06034132

Studies
Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid

NCT06034132

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Dental Implants

Interventions

Stock healing abutments
Compoiste healing abutments

Countries

Egypt

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 15, 2023Actual

Completion Date

Jun 15, 2023Actual

First Submitted Date

Sep 5, 2023

First Submission Date that Met QC Criteria

Sep 5, 2023

First Posted Date

Sep 13, 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

Sep 5, 2023

Last Update Posted Date

Sep 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversityPrincipal Investigator

Lead Sponsor

Alexandria UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental		Other: Compoiste healing abutments
Control group	Active Comparator		Other: Stock healing abutments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stock healing abutments	Other	2ND stage surgery will be performed and stock healing abutment were placed	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in MMP8 levels	Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit	at 2 weeks and 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in gingival condition	Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation = mild inflammation = mild inflammation = moderate inflmmation = severe inflammation	at 2 weeks and 4 weeks
Change in gingival bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with no systemic and/or oral health disease
absence of any lesions in the oral cavity
wide band of keratinized tissue more than 1mm at implant site

Exclusion Criteria:

smoking more than 20 cigarettes per day
localized radiation therapy of the oral cavity,
antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria Faculty of Dentistry		Alexandria			Egypt