臨床研究等提出・公開システム

Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study (Keratinized tissue reconstruction with gingival micro-grat.)

Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study (Keratinized tissue reconstruction with gingival micro-grat.)

4

Patients who received the dental implant treatment and were recognized the keratinized gingival defect or insufficient thickness (<2mm). Also, patients who received the oral health care and maintain the good condition of plaque control. A total of 4 patients, including 1 man and 3 females (age range, 58 to 71 years; mean age, 66 years) were enrolled in this study.

A total of 4 patients, who needed keratinized gingiva reconstruction around dental implants, received a transplantation of atelocollagen-matrix (TERUDERMIS) with MGCTs micronized by using Rigenera system. The duration of the intervention was 4 weeks after surgery. The primary endpoint is to assess the safety/tolerability of the protocol. The secondary endpoints are to evaluate the efficacy of micro-graft with MGCTs on keratinized gingival tissue augmentation.

As a result, no adverse events occurred including systemic complications, excessive immune reactions, severe infection, or excessive post-operative complications in 16-weeks follow-up. Additionally, there was no peri-implant mucositis, and stability of dental implants was maintained after micro-graft transplantation. Therefore, this clinical study demonstrated that transplantation of micro-graft with MGCT could be applied safety for keratinized gingival tissue reconstruction, and shows no adverse effects in dental implant treatment.

This first clinical study demonstrated that using micro-graft with MGCTs did not causes any irreversible adverse events, and showed efficacy of micro-graft with MGCTs on keratinized gingival tissue reconstruction in dental implant therapy.

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.

June. 30, 2022

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs072180075

Asahina Izumi

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

asahina@nagasaki-u.ac.jp

Sumita Yoshinori

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

+81-95-819-7706

y-sumita@nagasaki-u.ac.jp

Complete

Mar. 01, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

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.

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.

Both

Defect of keratinized gingiva surrounding dental implants

Intervention period: 4 weeks
Intervention volume: 3x3x3mm size of gingival connective tissue: one or two pieces
Number of times of Intervention: 1 time

-

-

-

-

Safety, adverse events

Efficacy (Reconstruction of Keratinized gingival tissue)

+81-95-819-7229

Mar. 14, 2019

none