Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth

The Dental Hospital of Zhejiang University School of Medicine36 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontitis

Interventions

alveolar ridge preservationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

change from baseline horizontal width of ridge at 6 months

horizontal width of ridge at 1, 3, 5mm below crest

Time frame: baseline, at 6 months

change from baseline vertical height of ridge at 6 months

vertical height of ridge at the buccal and palatal/lingual plates

Time frame: baseline, at 6 months

Secondary Outcomes

width of keratinized tissue

measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe

Time frame: at 6 months

thickness of mucosa

measured at the mid-buccal aspect using an endodontic file with a rubber stop

Time frame: at 6 months

postoperative pain

using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

Time frame: at 2 weeks

Central Contacts

Weida Li, master

CONTACT

0571-87219287 kyb@zjkq.com.cn

Data from ClinicalTrials.gov

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