Periodontitis Periodontitis
Conditions
Interventions
Flap surgery will be performed and patients will be randomly assigned to receive either Regros alone or a combination of Regros and Refit Dental.
Sponsors
Takashiba Shogo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be selected from patients who meet all of the following criteria. They must be at least 18 years of age, capable of providing written informed consent, and either systemically healthy or under adequate medical control for any systemic conditions. Additionally, they must be non-smokers at the time of enrollment. 1. Patients diagnosed with periodontitis for whom flap surgery is deemed necessary by the attending dentist. 2. Patients presenting with probing pocket depths of 4mm or more, and vertical bone defects of at least 3mm in depth. Vertical bone loss should be classified as two- to three-wall defects (including combined defects), and furcation involvement should be limited to Class II. 3. Patients with tooth mobility of degree 2 or less, and with sufficient keratinized gingiva to allow for flap surgery, as determined by the attending dentist.
Exclusion criteria
Exclusion criteria: Patients who do not meet the inclusion criteria or who meet any of the following conditions shall not be enrolled in this study: 1) Patients taking prohibited concomitant medications (for example, bisphosphonates or other drugs used for osteoporosis or bone metabolism, anticancer agents, anticoagulants, or immunosuppressants). 2) Patients with current malignancies or a history of malignancy. 3) Patients with a history of bisphosphonate use or a current diagnosis of osteoporosis. 4) Patients presenting with abnormal gingival overgrowth or a history thereof. 5) Patients with findings suggestive of oral malignancies, precancerous lesions, or suspicion of such conditions. 6) Patients with a history of anaphylaxis or those with severe allergies. 7) Patients known to be allergic to porcine collagen-containing products. 8) Patients with periodontal conditions other than marginal periodontitis that may affect periodontal healing (such as periapical periodontitis or root fracture). 9) Patients expected to undergo treatments within 36 weeks after surgery that may interfere with the evaluation of efficacy or safety. 10) Patients with prosthetic restorations or other conditions that interfere with accurate clinical attachment level measurement. 11) Patients with evident residual inflammation due to oral treatments performed within the past 3 months. 12) Patients with serious hematologic disorders or hormonal or metabolic bone diseases. 13) Patients suspected of having abnormalities in calcium metabolism involving the kidneys, digestive system, or collagen diseases. 14) Patients undergoing dialysis or currently receiving steroid therapy. 15) Patients with severe comorbidities (such as infections, immunodeficiencies, cardiac diseases) or psychiatric disorders that would impair their ability to comply with study requirements. 16) Patients with alcohol or drug dependency. 17) Patients with diabetes mellitus whose glycemic control is inadequate (HbA1c >= 6.5%). 18) Patients who are pregnant, possibly pregnant, breastfeeding, or intending to become pregnant during the study period. 19) Patients residing in remote areas or otherwise deemed likely to have difficulty attending scheduled follow-up visits. 20) Patients whose social or home environment may interfere with adherence to study requirements. 21) Patients who have participated in other clinical studies involving investigational drugs or devices within the past 3 months. 22) Any other patients whom the principal investigator or sub-investigator judges to be unsuitable for the combined use of Regroth and Refit Dental, or for participation in this study in general.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events whose causal relationship with combination therapy of Regroth and Refit Dental cannot be ruled out | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Clinical attachment gained 36 weeks after surgery (mm) 2.Rate of increase of new alveolar bone after 36 weeks of surgery 3.Amount of increase in applied alveolar bone after 36 weeks of surgery 4.Amount of improvement in periodontal pocket depth (mm) after 36 weeks of surgery 5.Changes in chewing ability after 36 weeks of surgery 6.Changes in periodontal pathogenic bacterial flora 36 weeks after surgery | — |
Contacts
Public ContactKeisuke Okubo
Okayama University Hospital
Outcome results
None listed