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Soft Tissue Contouring with 3D-Printed Zirconia Abutments: A Randomized Controlled Trial

Prospective Randomized Controlled Clinical Study on Soft Tissue Shaping with 3D-Printed Zirconia Healing Abutments in Posterior Regions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128556
Enrollment
Unknown
Registered
2026-07-22
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of single posterior tooth

Interventions

Experimental group:Placement of 3D-printed zirconia healing abutment

Sponsors

Shanghai Stomatological Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Single-tooth loss in the posterior region was scheduled for implant-supported rehabilitation. Cone-beam computed tomography (CBCT) evaluation revealed adequate bone quantity and quality at the intended implant site, allowing placement of standard-diameter implants without additional bone augmentation procedures such as guided bone regeneration (GBR). 2.Patients presented with remaining natural teeth (especially anterior teeth and adjacent teeth) free of obvious black interdental triangles, with complete filling of the interdental papilla beneath contact points. 3.Oral hygiene and treatment compliance: Patients shall present satisfactory oral hygiene with a plaque index of <=1. They are capable and willing to maintain optimal oral hygiene and commit to completing all scheduled follow-up visits. 4.Informed Consent: Subjects voluntarily participate in this study, fully understand the research protocol, and sign the written informed consent form. 5. Age and Health Status: Aged 18-65, with an American Society of Anesthesiologists (ASA) classification of I or II, in good overall health, and capable of withstanding conventional dental implant surgery.

Exclusion criteria

Exclusion criteria: 1.Systemic Diseases: Patients with uncontrolled systemic disorders, including uncontrolled diabetes mellitus (glycated hemoglobin, HbA1c > 7.5%), osteoporosis, immunodeficiency diseases, coagulation disorders, or malignant tumors. 2.Adverse Habits and Medical History: Heavy smokers with a daily cigarette consumption of more than 10 cigarettes; patients with a history of head and neck radiotherapy; subjects receiving or having previously received intravenous bisphosphonate therapy. 3.Local Oral Conditions: Presence of untreated periodontitis or peri-implantitis; severe bruxism or clenching habits; acute infection or inflammation within the edentulous site; severe occlusal disharmony. 4.Special Physiological Status: Pregnant or lactating women. 5.Allergy History: Subjects with known hypersensitivity to titanium, zirconia, or other materials involved in this research. 6.Other Exclusion Criteria: Subjects with psychiatric or psychological disorders that render them unable to cooperate with treatment and follow-up assessments; any other conditions judged by the investigators to render participants ineligible for enrollment in this trial.

Design outcomes

Primary

MeasureTime frame
Gingival papilla filling ratio;

Secondary

MeasureTime frame
Patient satisfaction;Modified Bleeding Index,MBI;Modified Plaque Index, MPIL;

Countries

China

Contacts

Public ContactWu Yuqiong

Shanghai Stomatological Hospital, Fudan University

wyq192131@126.com+86 21 53315691

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026