Clinical trial NCT05258019: Site Preservation After Tooth Extraction
Official title: Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteogenesis Imperfecta
Total Absence of Permanent Teeth
Tooth Socket
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have teeth cannot be retained and are willing to do dental implant treatment at the teeth extration site.

Brief summary: 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.


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.

Primary outcomes:
measure: Changes in the alveolar crest height - central
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Changes in the alveolar crest width - central
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
Secondary outcomes:
measure: Changes in the alveolar bone width - different depths
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Changes in the alveolar bone height - different horizontal sites
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Soft tissue thickness
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Plaque index (PLI)
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Bleeding index (BI)
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Probing depth (PD)
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Phenotype assessment
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery
measure: Pain degree
timeFrame: up to 12 weeks after Dental extraction or site preservation surgery.
Other outcomes:
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