Zirconia-based composite customized healing abutments for healthier soft tissue around dental implants
Peri-implant Soft Tissue Response to Direct Zirconia-Based Composite Customized Healing Abutment: A Randomized Controlled Clinical Study With Biochemical Analysis
This test will compare zirconia-based composite customized healing abutments with conventional composite abutments to see if they help gum tissue heal better after delayed dental implant placement in adults missing a tooth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abaseya) |
| Trial ID | NCT07095881 on ClinicalTrials.gov |
What this trial studies
Adults needing delayed dental implants will receive either a direct zirconia-based composite customized healing abutment or a conventional composite customized healing abutment placed at the time of implant placement and will be followed for three months. Clinical outcomes include pink esthetic score and papilla index measured at baseline and at 1, 2 and 3 months, while peri-implant sulcus fluid will be sampled with Periopaper to measure IL-1β at two months as a biochemical inflammation marker. The trial enrolls systemically healthy adults aged 20–50 with adequate implant primary stability (ISQ ≥70), a thick soft-tissue phenotype, and no need for bone or soft-tissue augmentation, excluding smokers, pregnant or lactating women, and vulnerable groups. All procedures and follow-up visits are performed at the Faculty of Dentistry, Ain Shams University in Cairo.
Who should consider this trial
Good fit: Adults 20–50 years old who are systemically healthy, non-smokers with good oral hygiene, have a missing tooth suitable for a standard implant without augmentation, primary implant stability (ISQ ≥70), at least six natural teeth in the same arch, and a thick soft-tissue phenotype.
Not a fit: Patients who smoke, have poor oral hygiene, require bone or soft-tissue augmentation, are pregnant or lactating, belong to vulnerable groups, or have a thin soft-tissue phenotype are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these zirconia-based composite abutments could reduce local inflammation and improve soft-tissue healing and esthetic outcomes around dental implants.
How similar studies have performed: Laboratory and some clinical studies indicate zirconia surfaces can be more biocompatible and provoke less inflammation, but the specific use of direct zirconia-based composite customized healing abutments is relatively novel and not yet widely validated clinically.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Cairo, Abaseya
- Faculty of Dentistry Ain Shams University — Cairo, Abaseya, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed A El Sayed, MSc Perio
- Email: ahmed.abdelmoteleb.std@dent.asu.edu.eg
- Phone: +201127999187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.