Alveolar Bone LossPhase 2/3PANORAMIXNCT02120053
Interest of Bone Substitute Material in Immediate Complete Denture
A Phase 2/3 study testing Conventional protocol and Bone substitute material group in people with Alveolar Bone Loss and Denture Complete Immediate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute
- What is being tested?
- Conventional protocol and Bone substitute material group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Mar 2018
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for maxillary immediate complete denture, presenting a Kennedy
- Class I partial dentition (bilateral posterior tooth loss)
- Over 18 years of age
- Healthy adhering gingiva
- Willing to participate in the study, able to sign the consent form
Who cannot join
- Medical conditions contraindicating oral surgery: progressive cancer history of radiotherapy in the head and neck region major neurological disease anti-coagulant treatment with prothrombin time<30% valvulopathy, hematologic disease, agranulocytosis, serious heart failure, recent myocardial infarction < 5 years immune deficiency, AIDES osteomalacia hepatic or renal insufficiency unregulated diabetes long-term steroids treatment bisphosphonates
- Allergy to collagen
- Pregnant or nursing women
- Persons specially protected
- Non-affiliated with the social security system persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.
The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.
Read more
After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.
However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.
Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.
- Conditions
- Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute, Replacement Material, Bone
- Being tested
- Conventional protocol, Bone substitute material group
- Keywords
- Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional protocolDevice
Teeth extractions and conventional immediate complete denture placement
Bone substitute material groupDevice
Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
| Study group | Role | What they receive |
|---|---|---|
| Bone substitute material group | Experimental | Immediate denture placement following extractions and alveolar sockets filling with bone substitute material Receives: Device: Bone substitute material group |
| Conventional protocol | Active comparator | Immediate denture placement following the conventional protocol Receives: Device: Conventional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets
Measured: one year (365 days)
Secondary outcomes (1)
Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
To compare bone ridge width one year after maxillary immediate complete denture placement with and without bone substitute material in incisive-canine sockets: height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
Measured: Day 10, Day 90, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
- Investigators
- Christophe Rignon-Bret, DDS, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120053
- Sponsor's protocol ID
- P111116
- Other IDs
- AOR12032
- Acronym
- PANORAMIX
- Status last verified
- Sep 2017
- First submitted
- 15 Apr 2014
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
PubMed 9203100Tallgren A, Lang BR, Walker GF, Ash MM Jr. Roentgen cephalometric analysis of ridge resorption and changes in jaw and occlusal relationships in immediate complete denture wearers. J Oral Rehabil. 1980 Jan;7(1):77-94. doi: 10.1111/j.1365-2842.1980.tb01466.x.
PubMed 6987348Park JB. Healing of extraction socket grafted with deproteinized bovine bone and acellular dermal matrix: histomorphometric evaluation. Implant Dent. 2010 Aug;19(4):307-13. doi: 10.1097/ID.0b013e3181e5abbc.
PubMed 20683287Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.
PubMed 20070748Rignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.
Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.
PubMed 27206923
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02120053
- Acronym / sponsor ID
- PANORAMIX / P111116
- Conditions
- Alveolar Bone Loss, Denture Complete Immediate, Bone Substitute, Replacement Material, Bone
- Keywords
- Immediate complete denture, Alveolar ridge resorption, Alveolar bone loss, Bone substitute material, Edentulism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- Oct 2013
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 22 Apr 2014 (estimated)
- 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.
More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.
The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.
After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.
However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.
Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone substitute material group | Experimental | Device: Bone substitute material groupImmediate denture placement following extractions and alveolar sockets filling with bone substitute material |
| Conventional protocol | Active comparator | Device: Conventional protocolImmediate denture placement following the conventional protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates for maxillary immediate complete denture, presenting a Kennedy
- Class I partial dentition (bilateral posterior tooth loss)
- Over 18 years of age
- Healthy adhering gingiva
- Willing to participate in the study, able to sign the consent form
Key exclusion criteria (5 listed)
- Medical conditions contraindicating oral surgery: progressive cancer history of radiotherapy in the head and neck region major neurological disease anti-coagulant treatment with prothrombin time<30% valvulopathy, hematologic disease, agranulocytosis, serious heart failure, recent myocardial infarction < 5 years immune deficiency, AIDES osteomalacia hepatic or renal insufficiency unregulated diabetes long-term steroids treatment bisphosphonates
- Allergy to collagen
- Pregnant or nursing women
- Persons specially protected
- Non-affiliated with the social security system persons
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 |
|---|---|---|
| Conventional protocolTeeth extractions and conventional immediate complete denture placement | Device | Conventional protocol |
| Bone substitute material groupTeeth extractions and sockets filling with bone replacement material before immediate complete denture placement | Device | Bone substitute material group |
Primary outcome
Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets
Time frame: one year (365 days)
1 secondary outcome
Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year
Time frame: Day 10, Day 90, Day 365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 9203100Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
- Background: PubMed 6987348Tallgren A, Lang BR, Walker GF, Ash MM Jr. Roentgen cephalometric analysis of ridge resorption and changes in jaw and occlusal relationships in immediate complete denture wearers. J Oral Rehabil. 1980 Jan;7(1):77-94. doi: 10.1111/j.1365-2842.1980.tb01466.x.
- Background: PubMed 20683287Park JB. Healing of extraction socket grafted with deproteinized bovine bone and acellular dermal matrix: histomorphometric evaluation. Implant Dent. 2010 Aug;19(4):307-13. doi: 10.1097/ID.0b013e3181e5abbc.
- Background: PubMed 20070748Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.
- BackgroundRignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.
- Derived from this study: PubMed 27206923Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.
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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.
Christophe Rignon-Bret, DDS, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conventional protocol and Bone substitute material group in people with Alveolar Bone Loss and Denture Complete Immediate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Oct 2017. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets (time frame: one year (365 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120053, which also lists 6 linked publications.
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 3 Oct 2017.