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Clinical Evaluation of Xenograft Collagen Matrix for Soft Tissue Augmentation Concurrent with Posterior Implant Placement: A Prospective Study

Clinical Evaluation of Xenograft Collagen Matrix for Soft Tissue Augmentation Concurrent with Posterior Implant Placement

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106181
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-07-25
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Dentition defect

Interventions

Control group:Conventional placement of 2-mm healing abutments without soft tissue augmentation during posterior implant surgery
Test group:Soft tissue augmentation utilizing Fibro-Gide concurrent with posterior implant placement

Sponsors

Affiliated Stomatological Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >=18 years old with informed consent 2. Healed extraction sockets at the implant site 3. Full-mouth probing depth (PD) < 20% and plaque index (PI) < 20% 4. Requirement for at least one implant placement in the posterior region 5. No need for bone augmentation procedures 6. No history of soft or hard tissue augmentation at the surgical site 7. Minimum 2 mm keratinized gingival width in bucco-lingual/palatal dimension 8. Vertical soft tissue thickness < 2 mm, requiring soft tissue augmentation

Exclusion criteria

Exclusion criteria: 1. Uncontrolled systemic diseases; 2. Uncontrolled periodontitis; 3. Heavy smoking (>10 cigarettes/day); 4. Diseases affecting connective tissue metabolism; 5. Allergy to collagen-based biomaterials.

Design outcomes

Primary

MeasureTime frame
Vertical soft tissue thickness;

Secondary

MeasureTime frame
Keratinized mucosa width;Marginal bone level ;Complication rate;Periodontal Parameters——probing depth, bleeding on probing, plaque index);Three-dimensional volumetric change of soft tissue at the surgical site;

Countries

China

Contacts

Public ContactHe Fuming

The Affiliated Stomatology Hospital Zhejiang University School of Medicine

hfm@zju.edu.cn+86 135 1681 7697

Outcome results

None listed

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