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

September 5, 2023 updated by: Hams Hamed Abdelrahman, Alexandria University

Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: Stock healing abutments
2ND stage surgery will be performed and stock healing abutment were placed
Experimental: Test group
Other: Compoiste healing abutments
2ND stage surgery will be performed and composite healing abutment were placed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gingival condition
Time Frame: at 2 weeks and 4 weeks

Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation

  1. = mild inflammation
  2. = mild inflammation
  3. = moderate inflmmation
  4. = severe inflammation
at 2 weeks and 4 weeks
Change in gingival bleeding
Time Frame: at 2 weeks and 4 weeks
Bleeding index will be recorded as present or absent
at 2 weeks and 4 weeks
Change in plaque accumulation
Time Frame: at 2 weeks and 4 weeks

Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.

Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.

Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
at 2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Implants_2022_MP8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe