NCT06034132

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 5, 2023

Last Update Submit

September 5, 2023

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Change in gingival condition

    at 2 weeks and 4 weeks

  • Change in gingival bleeding

    at 2 weeks and 4 weeks

  • Change in plaque accumulation

    at 2 weeks and 4 weeks

Study Arms (2)

Test group

EXPERIMENTAL
Other: Compoiste healing abutments

Control group

ACTIVE COMPARATOR
Other: Stock healing abutments

Interventions

Stock healing abutmentsOTHER

2ND stage surgery will be performed and stock healing abutment were placed

Control group
Compoiste healing abutmentsOTHER

2ND stage surgery will be performed and composite healing abutment were placed

Test group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

EG(1)