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

JRCT ID: jRCTs072180075

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Defect of keratinized gingiva surrounding dental implants
• Date of first enrollment: 16/03/2017
• Target sample size: 5
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Safety, adverse events
• Secondary Outcome: Efficacy (Reconstruction of Keratinized gingival tissue)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Asahina Izumi
• Secondary ID(s): UMIN000027150