An observational study in Osteogenesis Imperfecta, Total Absence of Permanent Teeth and Tooth Socket, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's planned enrollment of 88 is above the median of 75 across 23 observational studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have teeth cannot be retained and are willing to do dental implant treatment at the teeth extration site.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first group of patients selected for site preservation will be performed with Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction
The second group of patients selected for site preservation will be performed with Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction
The third group of patients selected will be performed without site preservation after tooth extraction, and only conventional healing
Changes in the alveolar crest height - central
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
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Changes in the alveolar crest width - central
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
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Changes in the alveolar bone width - different depths
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
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Changes in the alveolar bone height - different horizontal sites
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
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Soft tissue thickness
The thickness of soft tissue will be measured at middle, central, and distal sites of both buccal-lingual sides,3mm from free gingival margin
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Plaque index (PLI)
Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Bleeding index (BI)
Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Probing depth (PD)
Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Phenotype assessment
Whether thick or thin gingival biotype will be detected by the transparency of the soft tissue while periodontal probing diagnosis
Time frame: up to 12 weeks after Dental extraction or site preservation surgery
Pain degree
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)
Time frame: up to 12 weeks after Dental extraction or site preservation surgery.
No study locations are listed for this record.
Start is estimated for Nov 2023; primary completion for Oct 2026, 35 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University →