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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06034132
Other study ID # Implants_2022_MP8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date June 15, 2023

Study information

Verified date September 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Stock healing abutments
2ND stage surgery will be performed and stock healing abutment were placed
Compoiste healing abutments
2ND stage surgery will be performed and composite healing abutment were placed

Locations

Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in MMP8 levels Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit at 2 weeks and 4 weeks
Secondary 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
Secondary Change in gingival bleeding Bleeding index will be recorded as present or absent at 2 weeks and 4 weeks
Secondary Change in plaque accumulation 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
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