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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
View:

• Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004).

• Both genders.

• Age from 20-50 years.

• Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019).

• Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016).

• Sound Mesial and distal neighboring teeth.

• At least 6 natural teeth remaining in the same arch .

• Mouth opening ≥ 30mm.

• Thick phenotype.

Locations
Other Locations
Egypt
Faculty of Dentistry Ain Shams University
RECRUITING
Cairo
Contact Information
Primary
Ahmed A El Sayed, MSc Perio
ahmed.abdelmoteleb.std@dent.asu.edu.eg
+201127999187
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 22
Treatments
Active_comparator: Zirconia-based composite customized healing abutment
Participants in this arm will receive a customized healing abutment made of Zirconia-based composite material fabricated chairside.~The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.~The abutment is placed immediately after implant placement and will remain in place for 3 months.
Active_comparator: Conventional composite customized healing abutment
Participants in this arm will receive a customized healing abutment made of conventional composite material fabricated chairside.~The abutment will be designed to mimic the emergence profile of the final prosthesis, aiming to optimize soft tissue shaping and healing.~The abutment is placed immediately after implant placement and will remain in place for 3 months.
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov