NCT07095881 Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment
| NCT ID | NCT07095881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Missing Tooth |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2025-01-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire (Pendleton et al., 2004). 2. Both genders. 3. Age from 20-50 years. 4. Missing tooth to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures (Beretta et al., 2019). 5. Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor (Baltayan et al., 2016). 6. Sound Mesial and distal neighboring teeth. 7. At least 6 natural teeth remaining in the same arch . 8. Mouth opening ≥ 30mm. 9. Thick phenotype. Exclusion Criteria: 1. Poor oral hygiene condition. 2. Pregnant and lactating females. 3. Smokers. 4. Vulnerable groups (Prisoners and handicaps).
Contact & Investigator
Hadeel G Salem, Lecturer
STUDY DIRECTOR
Faculty of Dentistry - Ain Shams University
Frequently Asked Questions
Who can join the NCT07095881 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 50 Years, studying Missing Tooth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07095881 currently recruiting?
Yes, NCT07095881 is actively recruiting participants. Contact the research team at ahmed.abdelmoteleb.std@dent.asu.edu.eg for enrollment information.
Where is the NCT07095881 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07095881 clinical trial?
NCT07095881 is sponsored by Ain Shams University. The principal investigator is Hadeel G Salem, Lecturer at Faculty of Dentistry - Ain Shams University. The trial plans to enroll 22 participants.