Patient selection and study design
fasting blood glucose, Obese, inflammation, periodontitis, allergy, tooth, diabetes
UNCONTROLLED HYPERTENSION, PERIAPICAL PERIODONTITIS, OBESE, INFLAMMATION, PERIODONTITIS, ALLERGY, DIABETES
The study was approved by the Clinical Research Ethics Committees of the Academic Center for Dentistry of Amsterdam (code ACTA 202061), Vrije Universiteit Amsterdam, The Netherlands, and Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine (code SH9H-2019-T231-4), China. This trial was conducted following the international standard for clinical investigations with medical devices (ISO 14155:2020). Written informed consent was obtained from all participants.A total of 40 patients were recruited in this study (15 in rhBMP-2/BioCaP/β-TCP group, 15 in β-TCP group, and 10 in the natural healing group). All patients met the selection criteria shown in Tables Inclusion criteria• Patients over the age of 18 years• The study includes patients who have undergone the extraction of a single-root tooth based on appropriate indications for tooth extraction• Patients whose tooth extraction site has been classified as either EDS-1 or EDS-2 according to the classification system developed by N. Caplanis et al. [• After the tooth extraction, implant surgery will be the follow-up treatment for these patients• Before participating in the trial, all subjects provided their voluntary and informed consent to participate in the studyExclusion criteria• Patients with conditions considered absolute contraindications for oral implant treatment based on the criteria established by Debby Hwang et al. [• Patients with uncontrolled local inflammation in the extracted or adjacent teeth, including uncontrolled periodontitis (periodontal probing depth > 4 mm) and acute periapical periodontitis• Patients with uncontrolled diabetes, where fasting blood glucose is still ≥ 8.8 mmol/L despite drug use• Patients with severe uncontrolled hypertension (blood pressure > 180/100 mmHg)• Obese patients with a body mass index (BMI) > 28 kg/m• Patients who have continuously used antibiotics or chronic anti-inflammatory therapy (≥ three times per week) within the first four weeks after surgery• Patients who smoke or use tobacco equivalent/chewing tobacco more than ten cigarettes daily• Patients who have an allergy to the investigational product• Female patients who are pregnant or nursing or refuse to take any contraception• Patients whose compliance could be improved by the investigator• Patients who have participated in or are participating in clinical trials of other medical devices or drugs within the 30 days before Day 0Schematic of clinical trial procedure. Intra-oral photographs of socket preservation and dental implant surgery. 