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Augmentation of keratinized tissue around dental implant with combined application of a xenogeneic collagen matrix and the free gingival graft : a single arm clinical trial

Augmentation of keratinized tissue around dental implant with combined application of a xenogeneic collagen matrix and the free gingival graft : a single arm clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057670
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

lack of keratinized mucosa around dental implants

Interventions

test group:combined application of a xenogeneic collagen matrix and the free gingival graft

Sponsors

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. There is no active periodontal disease or systemic disease and the age is more than 18 years old; 2. After implantation in edentulous area (no more than 3 consecutive implants), the vestibular groove is shallow and the width of keratinized tissue is less than 2mm; 3. The patient has aesthetic or functional needs to increase the keratinized tissue around the implant; 4. The depth of full mouth periodontal probing shall not be greater than 5mm; 5. The whole mouth plaque index (FMPS) and the whole mouth bleeding index (FMBS) are less than 15%; 6. The patient has good compliance.

Exclusion criteria

Exclusion criteria: 1. Smoking; 2. Pregnant or lactating women; 3. Untreated patients with periodontal disease; 4. Patients with systemic diseases (diabetes, heart disease, malignant tumor and other surgical contraindications); 5. Long term medication needs (such as immunosuppressive drugs, phenytoin sodium and other drugs that affect mucosal healing and repair); 6. Patients during/after radiotherapy; 7. Patients allergic to collagen; 8. Patients with a history of gingival surgery in the surgical area.

Design outcomes

Primary

MeasureTime frame
width of keratinized mucosa;

Secondary

MeasureTime frame
thickness of keratinized mucosa;gingival index;probing depth;postoperative pain;patient satisfaction;dosage of postoperative analgesic;operation time;esthetic score;depth of recession;width of recession;

Countries

China

Contacts

Public ContactPeihui Ding

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

phding@zju.edu.cn+86 18957108518

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026