Alveolar Ridge PreservationNCT04719624
Novel Porous Bioceramic Material as a Bone Substitute
A study testing Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery) and Geistlich Bio-Oss (bone grafting surgery) in people with Alveolar Ridge Preservation, run by Orton Orthopaedic Hospital at 1 site in Finland.
Trial summary
The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery) and Geistlich Bio-Oss (bone grafting surgery)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2021to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have voluntarily signed the informed consent
- Females and males, 18 years to 80 years of age
- Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
- At least one adjacent teeth present
- At least 3 intact walls
- Subjects must be committed to the study and the required follow-up visits
Who cannot join
- Planned radiation or radiation during previous year in the tooth extraction area.
- Smoking
- Osteoporosis
- Uncontrolled periodontitis
- Alcohol or drug abuse
- Pregnant or breastfeeding women
Show all 11Show fewer
- Uncontrolled diabetes
- Local acute or chronic infection or presence of oral lesions or trauma
- Immunosuppressive disease, treatment, or medication
- Subject is part of the investigator team of this study or investigator's family member
- Subject is employee of one of the organizations involve in this study
Trial locations and contacts
1 site in 1 country.
Finland1 site
Oral Hammaslääkärit Oyj, Qmedical Pikku Huopalahti
Helsinki, 00170
About this study
Official title: Novel Porous Bioceramic Material as a Bone Substitute. Clinical Trial.
The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.
The primary hypothesis of the study is that Adaptos®-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss®).
Read the detailed description
The purpose of this study is to evaluate new synthetic Adaptos®-Si and Adaptos® in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.
Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos®-Si (one of the the two granula sizes), Adaptos®, or Geistlich Bio-Oss®. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.
The study device Bio-Oss® (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery), Geistlich Bio-Oss (bone grafting surgery), Tooth extraction without bone graft material, Adaptos® (bone grafting surgery)
- Keywords
- synthetic bone graft, Adaptos, extraction socket, dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptos®-Si [0.5-1 mm] (bone grafting surgery)Device
Also called Ridge preservation bone grafting after tooth extraction.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
Adaptos®-Si [1-2 mm] (bone grafting surgery)Device
Also called Ridge preservation bone grafting after tooth extraction.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
Geistlich Bio-Oss (bone grafting surgery)Device
Also called Ridge preservation bone grafting after tooth extraction.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
Tooth extraction without bone graft materialProcedure or surgery
After screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing.
Adaptos® (bone grafting surgery)Device
Also called Ridge preservation bone grafting after tooth extraction.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
| Study group | Role | What they receive |
|---|---|---|
| Adaptos-Si [0.5-1 mm] | Experimental | Bone augmentation, after tooth extraction, with Adaptos-Si [0.5-1 mm] (synthetic bone graft material) in combination with a gelatin sponge. Receives: Device: Adaptos®-Si [0.5-1 mm] (bone grafting surgery) |
| Adaptos-Si [1-2 mm] | Experimental | Bone augmentation, after tooth extraction, with Adaptos-Si [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. Receives: Device: Adaptos®-Si [1-2 mm] (bone grafting surgery) |
| Bio-Oss | Active comparator | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge. Receives: Device: Geistlich Bio-Oss (bone grafting surgery) |
| Empty extraction socket | Placebo comparator | Post-extraction the socket filled only by clot. Receives: Procedure: Tooth extraction without bone graft material |
| Adaptos [1-2 mm] | Experimental | Bone augmentation, after tooth extraction, with Adaptos [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. Receives: Device: Adaptos® (bone grafting surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge preservation, comparison between Adaptos-Si filled extraction sockets and empty sockets.
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between Adaptos-Si filled extraction sockets and empty sockets.
Measured: baseline, 5 months, and 10 months post-extraction
Secondary outcomes (3)
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparisons between extraction sockets filled with Adaptos-Si or Bio-Oss bone graft substitutes.
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between extraction sockets filled with Adaptos-Si or Bio-Oss bone graft substitutes.
Measured: baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between Adaptos filled extraction sockets and empty sockets.
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between Adaptos filled extraction sockets and empty sockets.
Measured: baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes.
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes.
Measured: baseline, 5 months, and 10 months post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jun 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orton Orthopaedic Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biomendex Oy, Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti, Tampere University
- Responsible party
- Sponsor
- Investigators
- Antero Salo, MD, DDS, PhD, Principal investigator, Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719624
- Sponsor's protocol ID
- AdaptosOral-001
- Status last verified
- Oct 2023
- First submitted
- 13 Jan 2021
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Porous Bioceramic Material as a Bone Substitute. Clinical Trial.
- ClinicalTrials.gov ID
- NCT04719624
- Acronym / sponsor ID
- AdaptosOral-001
- Conditions
- Alveolar Ridge Preservation
- Keywords
- synthetic bone graft, Adaptos, extraction socket, dental
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Orton Orthopaedic HospitalUniversity, hospital or other
- Collaborators
- Biomendex Oy, Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti, Tampere University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 22 Jan 2021 (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.
The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.
The primary hypothesis of the study is that Adaptos®-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss®).
Detailed description
The purpose of this study is to evaluate new synthetic Adaptos®-Si and Adaptos® in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.
Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos®-Si (one of the the two granula sizes), Adaptos®, or Geistlich Bio-Oss®. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.
The study device Bio-Oss® (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adaptos-Si [0.5-1 mm] | Experimental | Device: Adaptos®-Si [0.5-1 mm] (bone grafting surgery)Bone augmentation, after tooth extraction, with Adaptos-Si [0.5-1 mm] (synthetic bone graft material) in combination with a gelatin sponge. |
| Adaptos-Si [1-2 mm] | Experimental | Device: Adaptos®-Si [1-2 mm] (bone grafting surgery)Bone augmentation, after tooth extraction, with Adaptos-Si [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. |
| Bio-Oss | Active comparator | Device: Geistlich Bio-Oss (bone grafting surgery)Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge. |
| Empty extraction socket | Placebo comparator | Procedure: Tooth extraction without bone graft materialPost-extraction the socket filled only by clot. |
| Adaptos [1-2 mm] | Experimental | Device: Adaptos® (bone grafting surgery)Bone augmentation, after tooth extraction, with Adaptos [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have voluntarily signed the informed consent
- Females and males, 18 years to 80 years of age
- Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
- At least one adjacent teeth present
- At least 3 intact walls
Key exclusion criteria (11 listed)
- Planned radiation or radiation during previous year in the tooth extraction area.
- Smoking
- Osteoporosis
- Uncontrolled periodontitis
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptos®-Si [0.5-1 mm] (bone grafting surgery)Also: Ridge preservation bone grafting after tooth extraction.After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months. | Device | Adaptos-Si [0.5-1 mm] |
| Adaptos®-Si [1-2 mm] (bone grafting surgery)Also: Ridge preservation bone grafting after tooth extraction.After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months. | Device | Adaptos-Si [1-2 mm] |
| Geistlich Bio-Oss (bone grafting surgery)Also: Ridge preservation bone grafting after tooth extraction.After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months. | Device | Bio-Oss |
| Tooth extraction without bone graft materialAfter screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing. | Procedure or surgery | Empty extraction socket |
| Adaptos® (bone grafting surgery)Also: Ridge preservation bone grafting after tooth extraction.After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months. | Device | Adaptos [1-2 mm] |
Primary outcome
Alveolar ridge preservation, comparison between Adaptos-Si filled extraction sockets and empty sockets.
Time frame: baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between Adaptos-Si filled extraction sockets and empty sockets.
3 secondary outcomes
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparisons between extraction sockets filled with Adaptos-Si or Bio-Oss bone graft substitutes.
Time frame: baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between Adaptos filled extraction sockets and empty sockets.
Time frame: baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes.
Time frame: baseline, 5 months, and 10 months post-extraction
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antero Salo, MD, DDS, PhD principal investigator
Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery) and Geistlich Bio-Oss (bone grafting surgery) in people with Alveolar Ridge Preservation, run by Orton Orthopaedic Hospital at 1 site in Finland.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge preservation, comparison between Adaptos-Si filled extraction sockets and empty sockets. (time frame: baseline, 5 months, and 10 months post-extraction). 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 2 Nov 2023.