NCT07031856

Brief Summary

The aim of this clinical study is to compare CAD-CAM and 3D restorations in individuals with two hard tissue losses or restorations in their mouths. The main question it aims to answer is: Is there a difference between CAD-CAM and 3D restorations according to FDI criteria? Researchers will compare participants to see if there is a difference between the two restorations according to FDI criteria. In this split-mouth study, participants will be randomized to receive a CAD-CAM partial restoration on one tooth and a 3D partial restoration on the other tooth.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jul 2025Nov 2026

First Submitted

Initial submission to the registry

May 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

May 20, 2025

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of dental restorations evaluated using FDI World Dental Federation criteria

    Esthetic Properties Color match (shade stability) Surface staining Translucency/opacity Anatomical form preservation Functional Properties Fracture and retention Marginal adaptation (gap formation) Wear resistance Occlusal contact stability Biological Properties (Newly added) Postoperative hypersensitivity (pulp reactions) Secondary caries development Periodontal response (gingival inflammation, bleeding on probing) Tooth integrity (adjacent tooth structure)

    Baseline, six months, 12 months

Study Arms (2)

3D printer partial crown

EXPERIMENTAL

Participant with restoration produced with 3D printer

Other: 3D printer partial crown

Cad-Cam partial crown

OTHER

Participant with restoration produced with Cad-Cam

Other: Treatment as usual

Interventions

Comprasion of partial restorations made with 3D printer

3D printer partial crown

Cad-cam printer partial crown

Cad-Cam partial crown

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with systemic conditions that may affect the study process (e.g. diabetes, autoimmune diseases).
  • Patients with excessive bruxism or parafunctional habits.
  • Pregnant or lactating women.
  • Patients with gum disease or severe bone loss.
  • Patients with a history of allergic reactions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova Üniversitesi Diş Hekimliği Fakültesi

Adana, Sarıçam, 01250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental CariesTooth Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tooth DemineralizationStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 22, 2025

Study Start

July 1, 2025

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations