Periodontitis
Conditions
Brief summary
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.
Detailed description
The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.
Interventions
PROCEDUREalveolar ridge preservation
Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.
Sponsors
The Dental Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Need for molar extraction due to periodontal disease and plan for late implantation 3. No acute infection, such as abscess or effusion 4. Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is \>50% of the corresponding root length and the bone height of socket walls is at least 3 mm 5. Presence of one adjacent tooth to the extraction site
Exclusion criteria
1. Smoking 2. Pregnancy or lactation 3. Untreated periodontal disease 4. Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.) 5. Under radiotherapy 6. Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.) 7. Extraction of multiple adjacent teeth 8. Allergy to any of the materials used in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline horizontal width of ridge at 6 months | baseline, at 6 months | horizontal width of ridge at 1, 3, 5mm below crest |
| change from baseline vertical height of ridge at 6 months | baseline, at 6 months | vertical height of ridge at the buccal and palatal/lingual plates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| width of keratinized tissue | at 6 months | measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe |
| thickness of mucosa | at 6 months | measured at the mid-buccal aspect using an endodontic file with a rubber stop |
| postoperative pain | at 2 weeks | using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) |
Countries
China
Contacts
Primary ContactWeida Li, master
Outcome results
None listed