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A prospective, randomized controlled clinical study on the efficacy of endoscopic assisted non flap regeneration for severe periodontitis

A prospective, randomized controlled clinical study on the efficacy of endoscopic assisted non flap regeneration for severe periodontitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044681
Enrollment
Unknown
Registered
2021-03-25
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe periodontitis

Interventions

Experimental group:Non flap regeneration assisted by endoscope

Sponsors

Nanjing Stomatological Hospital Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The age is 18-65 years old, and the gender is unlimited. 2. According to the diagnostic criteria of international classification of periodontal diseases in 1999, the patients were clinically diagnosed as aggressive periodontitis; according to the staging criteria of periodontitis in the new international classification of periodontal diseases and peri implant diseases in 2018, the patients were classified as stage III C. 3. Only isolated lesions need surgical treatment, and all the following conditions are met: 1) PD >= 7 mm at baseline; 2) After debridement, there was a vertical bone defect on the adjacent surface of the tooth surface, and the depth of the vertical bone defect was more than or equal to 4 mm, with at least one bone wall; 3) Keratinized gingiva with a width of more than or equal to 2 mm can completely cover the bone defect and implant; 4) X-ray showed that the base of the bone bag was at least 3 mm in the crown of the root tip. 4. The teeth were treated with scaling and curettage within one month. 5. The amount of plaque control was less than 20% at baseline. 6. The furcation lesions of the test teeth were less than or equal to grade II, and the loosening degree was less than or equal to grade I.

Exclusion criteria

Exclusion criteria: 1. The experimental teeth had a history of open debridement within one year; 2. Known to be allergic to animal derived collagen; 3. Clinical or radiological findings showed that there were acute infection, apical lesions, root fracture, severe root deformity, cementum beads, hard to remove cementum enamel protrusion, untreated caries at the enamel cementum boundary (CEJ) or root surface, and the restoration reached subgingival and / or the edge of restoration at or below CEJ was not close; 4. All kinds of subjects can cause artifacts in oral imaging examination, such as: the study teeth and their adjacent teeth are metal dentures and porcelain fused to metal teeth; 5. Patients with history of diabetes or abnormal blood glucose detection (fasting blood glucose >= 7 mmol / L); 6. Abnormal liver and kidney function (AST, ALT >= 1.5 fold ULN, creatinine >= 1.5 fold ULN); 7. Patients with severe endocrine and metabolic diseases; 8. The patients with three-level hypertension had osteoporosis and autoimmune diseases; 9. Who is not suitable for surgery due to the history of malignant tumor or other serious diseases 10. Patients who were using steroids that interfere with calcium metabolism within 3 months prior to informed consent bookmarking.

Design outcomes

Primary

MeasureTime frame
Gingival Recession;Angle and height of bone absorption in X-ray films;Attachment Loss;Plaque Index;Probing Depth;Bleeding On Probing;

Countries

China

Contacts

Public ContactLI HOUXUAN

Nanjing Stomatological Hospital Medical School of Nanjing University

2307672675@qq.com+86 18795863036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026