Status:
NOT_YET_RECRUITING
Clinical Evaluation of Additive and Subtractive Onlay Restorations
Lead Sponsor:
Ayse Tugba Erturk Avunduk
Collaborating Sponsors:
Mersin University
Conditions:
CAD-CAM
Prospective Study
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether onlay restorations produced by additive manufacturing \[three-dimensional (3D) printing\] and subtractive manufacturing \[Computer-Aided Design/Comp...
Detailed Description
This prospective, randomized, split-mouth clinical trial is designed to evaluate the clinical performance of onlay restorations fabricated by two different digital manufacturing techniques-additive ma...
Eligibility Criteria
Inclusion
- Participant-Level Criteria
- Adults aged 18-84 years
- No active periodontal disease (probing depth ≤ 3 mm, no clinical attachment loss)
- No parafunctional habits such as bruxism, clenching, or foreign object chewing
- Willingness to attend regular follow-up visits during the study period
- Adequate oral hygiene status
- No history of systemic disease or medically stable condition if present
- No history of similar restorative procedures involving the target teeth Tooth-Level Criteria
- Vital posterior teeth (premolars or molars) confirmed by thermal or electric pulp testing; teeth requiring endodontic treatment or with necrosis will be excluded
- Permanent posterior teeth located in functional occlusion (premolar or molar region)
- Teeth with moderate structural loss suitable for onlay restorations, including mesio-occlusal (MO), disto-occlusal (DO), or mesio-occluso-distal (MOD) cavities with partial crown loss but sufficient remaining tooth structure not requiring full coverage
- Periodontally healthy teeth with no mobility, no clinical attachment loss, and probing depth ≤ 3 mm
- Teeth that can be matched in contralateral quadrants to allow split-mouth design (structurally and clinically comparable teeth)
- Teeth free from cracks, fractures, or internal resorption; supporting tissues without structural defects that may compromise restoration success
- Teeth with clearly defined preparation margins located in enamel or sound dentin; subgingival margins extending deep into the sulcus will not be included
- Teeth without previous extensive prosthetic restorations (crowns, inlays/onlays, or implant-supported restorations)
- Opposing natural teeth in stable occlusal contact with the restored tooth
Exclusion
- Teeth with pulp necrosis or a history of endodontic treatment (previous root canal therapy or non-vital teeth)
- Teeth with excessive tissue loss requiring full crown coverage and unsuitable for onlay restoration
- Teeth presenting with cracks, fractures, internal or external resorption, or structural defects compromising prognosis
- Advanced periodontal disease, including clinical attachment loss, furcation involvement, mobility, or probing depth \> 3 mm
- Teeth with subgingival cavity margins extending deep into the gingival sulcus, increasing periodontal risk
- Teeth with a history of fixed prosthetic restorations (previous crowns, inlays/onlays, or bridge restorations)
- Teeth lacking proximal contacts due to adjacent tooth absence, leading to compromised contact stability and occlusal load distribution
- Teeth in regions with orthodontic appliances or fixed retainers that may interfere with restorative procedures or evaluation
- Opposing teeth absent or lacking stable occlusal contact with the restoration site
- Patients with systemic diseases contraindicate elective dental treatment (e.g., uncontrolled diabetes, immunocompromised status)
- Pregnant or breastfeeding women
- Patients unable or unwilling to attend scheduled follow-up visits \[baseline (1 week), 6 months, 12 months, and 18 months\]
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT07195201
Start Date
November 15 2025
End Date
August 31 2027
Last Update
September 26 2025
Active Locations (1)
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1
Mersin University, Faculty of Dentistry, Department of Restorative Dentistry
Mersin, Yenisehir, Turkey (Türkiye), 33343