Osteogenesis ImperfectaNCT05258019
Site Preservation After Tooth Extraction
An observational study of Osteogenesis Imperfecta and Total Absence of Permanent Teeth, run by Nanfang Hospital, Southern Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteogenesis Imperfecta, Total Absence of Permanent Teeth, Tooth Socket
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who have teeth cannot be retained and are willing to do dental implant treatment at the teeth extration site.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation
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.
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane | The first group of patients selected for site preservation will be performed with Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction | |
| Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane | The second group of patients selected for site preservation will be performed with Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction | |
| Conventional healing after tooth extraction, without site preservation | The third group of patients selected will be performed without site preservation after tooth extraction, and only conventional healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 12 weeks after Dental extraction or site preservation surgery
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: up to 12 weeks after Dental extraction or site preservation surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Nov 2023 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258019
- Sponsor's protocol ID
- NFEC-2021-414
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation
- ClinicalTrials.gov ID
- NCT05258019
- Acronym / sponsor ID
- NFEC-2021-414
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane | – | –The first group of patients selected for site preservation will be performed with Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction |
| Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane | – | –The second group of patients selected for site preservation will be performed with Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction |
| Conventional healing after tooth extraction, without site preservation | – | –The third group of patients selected will be performed without site preservation after tooth extraction, and only conventional healing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who have teeth cannot be retained and are willing to do dental implant treatment at the teeth extration site.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteogenesis Imperfecta and Total Absence of Permanent Teeth, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Liu, Ph.D. (+86 20 62787153, liuqi0721@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the alveolar crest height - central (time frame: up to 12 weeks after Dental extraction or site preservation surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.