Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: alveolar ridge preservation.
- Who it may be relevant to
- Registry conditions: Periodontitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
Overview
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
- Procedure alveolar 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.
Primary outcome measures
- change from baseline horizontal width of ridge at 6 months [Time frame: baseline, at 6 months]
- change from baseline vertical height of ridge at 6 months [Time frame: baseline, at 6 months]
Secondary outcome measures (3)
- width of keratinized tissue [Time frame: at 6 months]
- thickness of mucosa [Time frame: at 6 months]
- postoperative pain [Time frame: at 2 weeks]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Need for molar extraction due to periodontal disease and plan for late implantation
- No acute infection, such as abscess or effusion
- 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
- Presence of one adjacent tooth to the extraction site
Exclusion criteria
- Smoking
- Pregnancy or lactation
- Untreated periodontal disease
- Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
- Under radiotherapy
- Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
- Extraction of multiple adjacent teeth
- Allergy to any of the materials used in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT05188196 · DHZhejiangU-2021（77）