Clinical trial Recruiting at 1 site Interventional Ages 20 to 50

Zirconia-based composite customized healing abutments for healthier soft tissue around dental implants

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

Run by Ain Shams University · NCT07095881 · Data updated 2026-11-12

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

Study typeInterventional
Ages20 Years to 50 Years
SexAll
Enrollment22 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Abaseya)
StatusRecruiting
StartedJanuary 6, 2025
Main results expectedJune 2026
Study endsDecember 2026
Registry record updatedJuly 31, 2025
Trial IDNCT07095881 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Faculty of Dentistry Ain Shams University
    Cairo, Abaseya, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.