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NCT Number: NCT05258019

Site Preservation After Tooth Extraction

This study is mainly targeted affected teeth which could not be retained, and patients are willing to undergo implant repair at the later stage. After teeth extraction, Geistlich Bio-Oss ® Particles or Bio-Oss ® Collagen are immediately implanted in the teeth extraction socket and covered with Bio-Gide ® collagen membrane for site preservation.Through postoperative follow-up, postoperative clinical and imaging objective indicators, combined with the subjective evaluation of surgeons and patients, and compared with conventional extraction treatment method, the study is aimed to evaluate the effectiveness of different site preservation of alveolar crest preservation, in order to reduce the alveolar bone width and height loss, effectively reduce alveolar bone absorption, or even achieve bone incrementation, thus to get the ideal site preservation effect, to improve the oral implant success rate, improve implant aesthetic score and patient satisfaction, provide more clinical standard reference of the clinical application of site preservation.

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Key information

Conditions

Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Skin and Connective Tissue Diseases Tooth Socket Total Absence of Permanent Teeth

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients willing to performed site preservation with Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction;
  • patients willing to performed site preservation with Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction;
  • patients willing to performed no site preservation after tooth extraction and only conventional healing.

Exclusion criteria

  • patients unwilling to sign the informed consent form and the letter of authorization;
  • patients has a potential systematic diseases;
  • patients had previously been treated with radiation therapy;
  • patients can not re-visit on time.

Treatment and study plan

Primary outcomes

  1. Changes in the alveolar crest height - central

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    The central alveolar bone height of the ideal implant site will be measured with CBCT at 3 months after tooth extraction or plus site preservation

  2. Changes in the alveolar crest width - central

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    The central alveolar bone width of the ideal implant site will be measured with CBCT at 3 months after tooth extraction alone or plus site preservation

Secondary outcomes

  1. Changes in the alveolar bone width - different depths

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    The width of the alveolar bone at 1,3,5, and 7mm below the alveolar crest will be measured with CBCT at 3 months after tooth extraction or plus site preservation

  2. Changes in the alveolar bone height - different horizontal sites

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    The height of the alveolar bone will be measured at the mesial, central and distal of buccal and lingual of alveolar crest,and the midpoint of the mesial and distal of interproximal sites with CBCT at 3 months after tooth extraction alone or plus site preservation

  3. Soft tissue thickness

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    The thickness of soft tissue will be measured at middle, central, and distal sites of both buccal-lingual sides,3mm from free gingival margin

  4. Plaque index (PLI)

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides

  5. Bleeding index (BI)

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides

  6. Probing depth (PD)

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides

  7. Phenotype assessment

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery

    Whether thick or thin gingival biotype will be detected by the transparency of the soft tissue while periodontal probing diagnosis

  8. Pain degree

    Time frame: up to 12 weeks after Dental extraction or site preservation surgery.

    The Visual Analogue Scale (VAS) pain score was evaluated: 0-10 (0: no pain; 1-3: slightly painful, acceptable; 4-6: painful, disrupt sleep, tolerable; 7-10: very painful, untolerable, affect sleep and diet)

Study contacts

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

Qi Liu, Ph.D.

CONTACT

[email protected]

+86 20 62787153

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 28, 2022
Registry last updated
Mar 30, 2023

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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