Dental Abutments With Different Surfaces in Two-Unit Implant Bridges

Is this trial a fit for you?

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

What this trial studies

This interventional study randomizes 44 adults with posterior tooth loss to receive either Xeal surface abutments or conventional titanium abutments for two-unit implant-supported bridges. All participants undergo standard implant placement and prosthetic procedures, with digital measurements of soft and hard tissue around the implants. Outcomes include peri-implant marginal bone loss, 3D digital tissue assessments, and analysis of the oral microbiome around the implants. The trial uses sealed envelope randomization to assign abutment type to each implant and compares results between the two groups over the planned follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age\>18 years old
2. Systemically healthy patients
3. Presence of edentulous areas in the mandibular or maxillary posterior region
4. Presence of natural teeth in the opposing arch
5. Periodontal health
6. Absence of oral or mucosal disease
7. Presence of bone suitable for implant placement with a minimum diameter of 3.75 mm and height of 8 mm
8. No need for simultaneous augmentation
9. Two-unit splinted implant-supported prosthesis
10. Prosthetic superstructure made of metal-supported porcelain-fused material
11. A healed maxillary or mandibular molar or premolar site (\>3 months) with sufficient bone available for implant placement without the need for bone grafting
12. Not having used any antibiotics in the 6 months immediately preceding the surgery.

Exclusion criteria:

1. Being outside the specified age range
2. Systemic disease
3. Patients who have received radiotherapy to the head and neck region
4. Severe bruxism or clenching
5. Patients who smoke more than 10 cigarettes per day
6. Use of drugs that suppress the immune system or impair healing, use of steroids or bisphosphonates
7. Patients with alcohol or substance dependence
8. Patients who do not comply with treatment
9. Pregnancy or breastfeeding
10. Patients with intellectual retardation
11. Untreated periodontal disease
12. Use of any drug or device within the 6 months immediately before surgery
13. Patients with conditions that could complicate surgical procedures/need advanced bone augmentation procedures
14. Allergy to any component of the implant or abutment
15. The need for bone or soft tissue reconstruction at the time of implant placement.

Where it's running

• Kutahya Health Sciences University Faculty of Dentistry
  Kütahya, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Berceste Guler Ayyildiz, Assoc. Prof. Dr.
• Email: berceste.guler@ksbu.edu.tr
• Phone: 905059359207

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

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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.