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Efficacy of xenogeneic soft tissue substitute for peri-Implant soft tissue height (STH) augmentation in second-stage surgery: a randomized clinical trial

Efficacy of xenogeneic soft tissue substitute for peri-Implant soft tissue height (STH) augmentation in second-stage surgery: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120922
Enrollment
Unknown
Registered
2026-03-23
Start date
2026-03-23
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Patients undergoing the second phase of dental implant surgery:The soft tissue thickness at the alveolar crest of the implant site is less than 2 mm

Interventions

experimental group:During the second surgery, a xenogeneic soft tissue substitute (Fibro-Gide) was applied simultaneously to cover the alveolar ridge and connect the healing abutment.
control group:During the second operation, a connective tissue graft was performed simultaneously to connect and heal the abutment.

Sponsors

Hospital of Stomatology, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Understand the implant restoration process and have signed the preoperative informed consent form, and can follow the requirements for follow-up; 2. Age 18 to 60 years old, gender not limited; 3. One single premolar or molar on both sides of the mandible needs to be extracted due to residual crown, crack, longitudinal crack, bottom perforation, internal or external resorption, etc., excluding free-end absence; 4. The soft tissue thickness at the alveolar crest of the implant site is less than 2 mm; 5. Use bone-level implants; 6. Good oral hygiene, and can maintain oral hygiene independently.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic diseases that may affect the postoperative healing period and/or bone integration, such as uncontrolled diabetes, hypertension, etc.; 2. Systemic or local bone diseases, such as bone tuberculosis, osteomyelitis, bone tumors, etc.; 3. Oral mucosal diseases; 4. Patients who have been taking special medications that may affect postoperative healing or bone integration for a long time; 5. Patients with contraindications for oral surgery; 6. Patients who have received radiotherapy or chemotherapy within the past 3 years; 7.Patients with uncontrolled periodontitis; 8. Patients with alcohol dependence, drug abuse, or other drug addiction; 9. Patients who smoke; 10. Patients who grind their teeth at night, clench their teeth, or have moderate or severe tooth wear; 11. Patients with periodontal inflammation or periapical inflammation adjacent to the teeth; 12. Patients using soft tissue-level implants; 13. Patients with insufficient hard tissue at the implant site and requiring bone augmentation.

Design outcomes

Primary

MeasureTime frame
supracrestal tissue height, STH;

Secondary

MeasureTime frame
Marginal Bone Loss, MBL;

Countries

China

Contacts

Public ContactShiyu Wu

Hospital of Stomatology, Sun Yat-sen University

wushy55@mail.sysu.edu.cn+86 158 7656 5480

Outcome results

None listed

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