bone defect of chronic periodontitis
Conditions
Interventions
Treatment group:Guid-Oss biomembrane
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be entered into the study: 1. Male or female, between 18-65 years of age and in good general health; 2. Must be willing and able to provide informed consent and be available for multiple follow-up visits for the duration of the study; 3. The patients with chronic periodontitis, reference to the 1999 international diagnostic standard with a new classification of periodontal disease; and 4. The study site must exhibit the following: (1) A probing pocket depth measuring 7 mm or greater at the baseline visit; (2) After surgical debridement, 4 mm or greater vertical bone defect (BD) with at least 1 bony wall; (3) 2 mm or greater keratinized tissue to allow complete tissue coverage of the defect and graft; and (4) Radiographic base of defect at least 3 mm coronal to the apex of the tooth; 5. Study teeth have been scaling and root planning with 2 month before the study; 6. During the study , only isolated lesion is required surgery; 7. Study tooth exhibiting mobility of no more than Grade I; 8. Study tooth exhibiting no furcation defect.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women intending to become pregnant during this study period; 2. Patients with history of diabetes or blood glucose was abnormal (7 mmol/L or higher fasting blood-glucose, liver and kidney dysfunction (AST, ALT 1.5 x ULN or higher, creatinine 1.5 x ULN or higher), patients with serious endocrine metabolic bone disease, patients who are using or have been used interference calcium metabolism steroids within 3 month before consent informed; 3. History of osteoporosis; 4. History of severe allergies; 5. History of autoimmune diseases; 6. History of cancer; 7. History of previous periodontal surgery on the study tooth; 8. Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ; 9. Dental imaging artifacts, such as: study tooth and its adjacent teeth with metal or porcelain denture; 10. History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking or smoking more than 10 cigarettes/day; 11. The subjects received the treatment of other studies within 30 days before the surgery; 12. Estimate adherence is poor, or has other unfavorable factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical attachment level (CAL), periodontal probing depth (PD), and X-ray showed the improvement of the hard tissue from baseline to week 24 composite scores of total effective rate (total effectiveness refers to the sum of significant efficiency and effective rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Linear Bone Growth (LBG) at 24 weeks;Change in percent bone fill from baseline to 24 weeks;Change in Gingival Recession (GR) from baseline to 24 weeks; | — |
Countries
China
Contacts
Public ContactRong Shu
9th People's Hospital, Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed