NCT07095881

Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment

Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if using zirconia-based composite customized healing abutment can have a favorable effect on peri implant soft tissue that may be related to the superior biological properties of zirconium nano particles regarding increased biocompatibility and decreased inflammatory response Patients that are eligible for implant placement The main question it aims to answer is: Does zirconia-based composite customized healing abutment have a significantly different effect on peri-implant soft tissue compared to conventional composite customized healing abutment in terms of biological properties or biocompatibility or inflammatory response? Researchers will compare between direct zirconia-based composite customized healing abutments vs conventional composite customized healing abutments placed simultaneously with delayed dental implant placement. Participants will be undergo the following procedures : A) Presurgical procedures: 1. Detailed clinical examination, full history, and radiographic examination (CBCT) will be performed initially to aid in patients' selection. 2. After enrollment, all participants will sign the informed consent. 3. All participants will be subjected to periodontal phase I treatment including periodontal supra- and sub-gingival debridement and oral hygiene instructions. B) Surgical procedures: 1. After local anesthesia administration, flap is raised, osteotomy site preparation, and implant will be placed. 2. Check the ISQ to exceed or equal 70 unit. 3. A customized Light-cured Direct Zirconia-Based Composite or A customized Light-cured Direct Convential Composite Healing Abutment will be placed. Then all participants should follow up at the following times : Baseline, 1,2 and 3 months after implantation.

Detailed description

Light-cured direct zirconia-based composite has many potential uses in dentistry, because of mechanical and biological reasons maintaining the health of peri-implant soft tissues during healing. Direct zirconia-based composite customized healing abutments have superior properties such as biocompatibility, chemical stability, antibacterial and mechanical properties. Aim of the study: This study will be carried out to compare zirconia-based composite customized healing abutments vs conventional composite customized healing abutment placed simultaneously with delayed dental implant placement. Materials and Methods: This will be done by clinical evaluation of peri-implant soft tissue changes. Moreover, peri-implant sulcus fluid (PISF) will be measured for the level of Interleukin-1 beta (IL-1β) in the gingival crevicular fluid. PICOTS Elements: Patient/Problem:Patients that are eligible for implant placement within inclusion criteria. Intervention: Zirconia-based composite customized healing abutment. Comparator: Conventional composite customized healing abutment. Outcome: Primary outcome : Clinical evaluation of peri-implant soft tissue changes via pink esthetic score and papilla index. Secondary outcome : Biochemical assessment of IL-1β level in the gingival crevicular fluid using Periopaper strip . Time: Baseline, 1,2 and 3 months after implantation. Biochemical assessment : after 2 months of implantation. Setting: Faculty of Dentistry, Ain Shams University. Clinical Relevance: The result will affect the gold standard in choosing the customized healing abutment material for implant patients, regarding which one offers better peri-implant soft tissue results, healing stimulation, and less inflammatory response.

Conditions

• Missing Tooth

Interventions

Type	Name	Description
OTHER	Zirconia-based composite customized healing abutment	using Zirconia-based composite in customized healing abutment fabrication
OTHER	Conventional composite customized healing abutment.	using conventional composite in customized healing abutment fabrication

Timeline

• Start date: 2025-01-06
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: Egypt