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Biomimetic Antimicrobial Oral Restoration Biomembranes: Fundamentals and Clinical Studies

Biomimetic Antimicrobial Oral Restoration Biomembranes: Fundamentals and Clinical Studies

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090846
Enrollment
Unknown
Registered
2024-10-14
Start date
2023-01-11
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Diabetes with single-tooth loss.

Interventions

study group:domestic porcine small intestinal submucosa absorbable biological membrane+Bio-oss
(study group) :domestic bovine pericardial tissue absorbable biological membrane+Bio-oss

Sponsors

School of Stomatology, The Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Stable diabetic patients (male or female, aged 18-65 years) with controlled fasting blood glucose (=8.8 mmol/L) through medication. 2. Patients with non-restorable single-tooth loss need dental implant restoration. 3. Implant sites oriented towards restoration, with insufficient buccal horizontal bone width but capable of providing initial implant stability, or with a socket bone width =3 mm. 4. Adequate keratinized gingiva at the ridge (=2 mm from ridge crest to mucogingival junction). 5. Sufficient vertical height at the ridge for safe implantation of =8 mm implants, or ridge height =5 mm. 6. Absence of significant bleeding, redness, pus discharge, or progressive inflammation in periodontal tissues; adjacent teeth with normal pulp vitality or root canal treatment meeting clinical restoration standards; mobility of adjacent teeth < Grade I; basic normal occlusion. 7. Patients with good compliance, willing to participate in this clinical trial, and able to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Untreated periodontitis (periodontal probing depth >4 mm). 2. Untreated acute or chronic apical periodontitis in adjacent teeth. 3. Oral precancerous lesions or oral cancer. 4. Occupying lesions in adjacent teeth (including cysts, tumors, etc.). 5. Cardiac disease (functional class II or above). 6. Patients with impaired or abnormal liver or kidney function. 7. Patients receiving full-dose radiation therapy, or a history of local radiation therapy to the head or neck within the last 3 months. 8. Patients requiring long-term high-dose steroid therapy. 9. Patients currently or within the past 3 months receiving medications (such as bisphosphonates) that may affect or promote bone metabolism. 10. Continuous antibiotic therapy or chronic anti-inflammatory treatment (=3 times per week) in the four weeks preceding surgery. 11. Drug addiction, alcohol abuse, substance abuse, or self-reported smoking/tobacco chewing equivalent to more than 10 cigarettes per day. 12. Patients with uncontrolled systemic diseases preventing implant surgery. 13. Physical or mental impairments affecting oral hygiene care. 14. Pregnant or breastfeeding women. 15. Patients considered non-compliant and unable to participate in the trial by the investigator. 16. Participation in other clinical trials involving drugs or devices within 30 days before surgery (day 0 of the study).

Design outcomes

Primary

MeasureTime frame
Comparison of horizontal buccal bone plate bone growth effects between two patient groups.Horizontal alveolar bone growth at 2 mm below the implant abutment at 6 months post-surgery.;

Secondary

MeasureTime frame
Comparison of postoperative wound healing conditions between two patient groups;Comparison of horizontal buccal bone plate bone growth effects between two patient groups.Horizontal alveolar bone growth at 0,4,6 mm below the implant abutment at 6 months post-surgery.;

Countries

China

Contacts

Public ContactNiu Lina

School of Stomatology, The Fourth Military Medical University

niulina831013@126.com+86 151 1483 8176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026