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Not yet recruiting NCT05258019

Site Preservation After Tooth Extraction

— Observational Osteogenesis Imperfecta Total Absence of Permanent Teeth Tooth Socket

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteogenesis Imperfecta, Total Absence of Permanent Teeth, Tooth Socket. Basic parameters: 18 years — 60 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Changes in the alveolar crest height - central [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Changes in the alveolar crest width - central [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
Secondary outcome measures (8)
  • Changes in the alveolar bone width - different depths [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Changes in the alveolar bone height - different horizontal sites [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Soft tissue thickness [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Plaque index (PLI) [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Bleeding index (BI) [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Probing depth (PD) [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Phenotype assessment [Time frame: up to 12 weeks after Dental extraction or site preservation surgery]
  • Pain degree [Time frame: up to 12 weeks after Dental extraction or site preservation surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05258019 · NFEC-2021-414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗