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Completed

NCT Number: NCT05902689

Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation

In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the Bio-Oss Collagen underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

About this study

Within 6 months after tooth extraction, the remaining alveolar ridge undergoes varying degrees of absorption, resulting in a decrease in horizontal width and vertical height of the alveolar ridge. The three-dimensional size change of the alveolar socket may affect the implantation of later implants and cause aesthetic and functional problems. Alveolar ridge preservation can maintain the volume of the alveolar socket, prevent soft tissue from growing into undesirable positions, slow down the absorption of the alveolar ridge to some extent, promote new bone formation, and maintain the shape of the extraction socket. This is crucial for later implant treatment for missing teeth. In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the Bio-Oss Collagen group underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, respectively, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The presence of one adjacent tooth at the extraction site
  • Adequate oral hygiene (plaque index <20%;bleeding on probing <25% )
  • Need for tooth extraction due to endodontic,periapical or periodontal disease.
  • Presence of ≥ 2 mm of keratinized tissue
  • the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls)

Exclusion criteria

  • Pregnancy or lactation
  • Smoking more than 10 cigarettes per day
  • with no evidence of acute infection such as severe swelling, suppuration at the extraction site
  • Uncontrolled periodontal disease
  • Existence of bone metabolic disease
  • history of malignancy, radiotherapy, or chemotherapy in the past 5 years
  • Administration of bisphosphonates
  • long-term use of NSAIDs
  • Alcohol or drug abuse
  • Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS)
  • Uncontrolled severe diabetes.( hemoglobin A1c >6.7%)

Treatment and study plan

alveolar ridge preservation with bio-oss collagen

Procedure

Alveolar ridge preservation with bio-oss collagen is a surgical method that reduces or limits the physiological resorption of alveolar bone after tooth extraction by implanting bio-oss collagen in the socket and covering the biological barrier membrane.

alveolar ridge preservation with sticky bone

Procedure

Alveolar ridge preservation with sticky bone is a surgical method that reduces or limits the physiological resorption of alveolar bone after tooth extraction by implanting sticky bone in the socket and covering the biological barrier membrane.

Primary outcomes

  1. Changes in horizontal ridge widths

    Time frame: baseline (before the surgery) and six months

    Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest

Secondary outcomes

  1. Changes in the vertical heights of the ridge

    Time frame: baseline (before the surgery) and six months

    Changes in the vertical heights of the ridge at the buccal and lingual crest areas

  2. Thicknesses of the keratinized gingiva

    Time frame: baseline (before the surgery) and six months

    Thicknesses of the keratinized gingiva at 2 and 4mm below the highest point of the gingiva

  3. width of the keratinized gingiva

    Time frame: baseline (before the surgery) and six months

    width of the keratinized gingiva

  4. percentages of newly formed bone

    Time frame: six months

    percentages of newly formed bone and residual bone substitute material in histologic sections

  5. The percentage of residual materials

    Time frame: six months postoperative

  6. The bone density ratio

    Time frame: six months postoperative

  7. The percentage of in alveolar bone volume within the region of interest (ROI) relative to the volume

    Time frame: at baseline

  8. Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire

    Time frame: one week post-surgery

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Apr 13, 2026

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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