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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06034132
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Implants	Other: Stock healing abutments; Other: Compoiste healing abutments	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)
• Actual Study Start Date: Jan 1, 2023
• Actual Primary Completion Date: Jun 15, 2023
• Actual Study Completion Date: Jun 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in MMP8 levels [at 2 weeks and 4 weeks]

   Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit

Secondary Outcome Measures

1. Change in gingival condition [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 = mild inflammation = mild inflammation = moderate inflmmation = severe inflammation

2. Change in gingival bleeding [at 2 weeks and 4 weeks]

   Bleeding index will be recorded as present or absent

3. Change in plaque accumulation [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT06034132
• Other Study ID Numbers: Implants_2022_MP8
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 13, 2023