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NCT Number: NCT05188196

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Peihui Ding, Doctor

CONTACT

[email protected]

18957108518

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alveolar ridge preservation

Procedure

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 outcomes

  1. change from baseline horizontal width of ridge at 6 months

    Time frame: baseline, at 6 months

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

  2. change from baseline vertical height of ridge at 6 months

    Time frame: baseline, at 6 months

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

Secondary outcomes

  1. width of keratinized tissue

    Time frame: at 6 months

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

  2. thickness of mucosa

    Time frame: at 6 months

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

  3. postoperative pain

    Time frame: at 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Weida Li, master

CONTACT

[email protected]

0571-87219287

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2022
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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