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A Randomized Controlled Trial on the Therapeutic Effect of Digital Occlusal Regulation Combined with All-Ceramic Periodontal Splint Fixation in Patients with Severe Chronic Periodontitis and Grade II–III Mobility of Mandibular Anterior Teeth

A Randomized Controlled Trial on the Therapeutic Effect of Digital Occlusal Regulation Combined with All-Ceramic Periodontal Splint Fixation in Patients with Severe Chronic Periodontitis and Grade II–III Mobility of Mandibular Anterior Teeth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128521
Enrollment
Unknown
Registered
2026-07-22
Start date
2026-07-22
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

Severe Chronic Periodontitis with Mandibular Anterior Teeth of Grade ?–? Mobility

Interventions

Experimental Group 2:Digital Occlusal Intervention Combined with CAD/CAM All-Ceramic Periodontal Splinting
Control Group:Conventional Occlusal Intervention Combined with Conventional Resin Periodontal Splinting
Experimental Group 1:Digital Occlusal Intervention Combined with Conventional Resin Periodontal Splinting

Sponsors

Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–65 years, any gender; 2.Confirmed diagnosis of Stage III or Stage IV periodontitis; 3.At least one mandibular anterior incisor presenting Miller tooth mobility grade II–III. Clinical and radiographic examinations confirm the tooth mobility is solely caused by severe periodontitis, excluding mobility resulting from endodontic lesions, dental trauma or other etiologies; 4.The affected tooth is clinically and radiographically evaluable as restorable: alveolar bone loss <= two-thirds of the root length, with no root fracture; 5.No missing teeth in the mandibular anterior region (i.e., complete mandibular anterior dentition); 6.The mobile tooth has no periapical lesions or pulpitis, or has undergone standardized root canal treatment; 7.Standard initial periodontal therapy (supragingival scaling, subgingival scaling and root planing) completed at our hospital, with well-controlled periodontal inflammation after treatment; 8.Voluntarily signs the informed consent form and is willing to comply with follow-up examinations and treatment procedures.

Exclusion criteria

Exclusion criteria: 1.Systemic diseases: diabetes mellitus (glycated hemoglobin >7%), osteoporosis, immunodeficiency disorders, long-term administration of corticosteroids or bisphosphonates; 2.Pregnant or lactating women; 3.Severe temporomandibular disorders or malocclusion that preclude routine occlusal adjustment; 4.Received occlusal adjustment or periodontal splinting within the past 6 months; 5.Uncontrolled periodontal inflammation after initial periodontal therapy; 6.Heavy smokers consuming more than 10 cigarettes per day who are unable to quit smoking; 7.Tooth mobility attributed to non-periodontal causes including chronic periapical periodontitis, dental trauma, root fracture, etc.; 8.Affected teeth deemed non-retainable based on clinical and radiographic assessment.

Design outcomes

Primary

MeasureTime frame
Changes in Clinical Attachment Level (CAL);Changes in Radiographic Bone Height;

Secondary

MeasureTime frame
Improvement of Tooth Mobility;Changes in Probing Depth (PD);Occlusal Interference Elimination Rate;Changes in Bleeding Index (BI);Patient Satisfaction;Incidence of Adverse Events Related to Periodontal Splints;Uniformity of Occlusal Force Distribution;

Countries

China

Contacts

Public ContactLing Wei

Peking University Hospital of Stomatology

331875341@qq.com+86 10 82307030

Outcome results

None listed

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