Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study

Phase 1

• Conditions: -; Defect of keratinized gingiva surrounding dental implants

• Registration Number: JPRN-jRCTs072180075
• Lead Sponsor: Asahina Izumi

Brief Summary

The objective of this clinical study is to assess the safety, and in part the efficacy of micro-graft with MGCTs on keratinized gingival tissue regeneration in dental implant therapy in a pilot study. A total of 4 patients received a transplantation of atelocollagen-matrix with MGCTs micronized by using Rigenera system. For 4 weeks after surgery, this study demonstrated that using micro-graft with MGCTs did not cause any irreversible adverse events, and showed efficacy of micro-graft with MGCTs.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2021-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Patients who received the dental implant treatment.
1. Patients who recognize the keratinized gingival defect or insufficient thickness (<2mm).
2. Patients who received the oral health care and maintain the good condition of Plaque Control.

Exclusion Criteria

1. Patients who have serious endocrine metabolic disease or autoimmune disease
2. Patients who have malignances, septicemia
3. Patients who have disorder of blood coagulation;
PT:more than 50 %
APTT:23.5 - 42.5seconds
4. Patients who have hepatitis function disorders or dysfunction;
GOT(AST):10 - 40 IU/L
GPT(ALT): 5 - 45 IU/L
5. Patients who have metabolic bone disease or skeletal dysplasia.
6. Patients who have pregnancy.
7. Patients who have dementia.
8. All patients are required to be nonsmokers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified