Alveolar Bone LossNCT04934813
Alveolar Ridge Preservation Techniques After Tooth Extraction
A study testing Alveolar ridge preservation in people with Alveolar Bone Loss, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar ridge preservation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2017to 25 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systematically healthy patients
- non-smokers
- no use of antibiotics for the last 3 months
- presence of a non-restorable single-rooted tooth in the maxilla.
Who cannot join
- Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Alveolar Ridge Preservation Techniques After Tooth Extraction: a Single- Center, Triple Blinded Randomized Clinical Trial.
The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.
Read the detailed description
Thrirty-six patients were randomly assigned in four treatment groups: A) freeze-dried bone allograft (FDBA) covered with collagen sponge (CS), B) FDBA covered with free gingival graft (FGG), C) demineralized bovine bone mineral xenograft (DBBM) covered with FGG and D) FGG without socket grafting. Clinical measurements were performed immediately after tooth extraction and 4 months later. The related outcomes pertained to both vertical and horizontal assessment of bone loss
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge preservation
- 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.
Alveolar ridge preservationOther
application of different bone graft and sealing means after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation with particulated allograft covered with collagen sponge. | Experimental | Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with collagen sponge (CS). Receives: Other: Alveolar ridge preservation |
| Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch | Experimental | Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG). Receives: Other: Alveolar ridge preservation |
| Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch | Experimental | Alveolar ridge preservation after tooth extraction. Demineralized bovine bone mineral xenograft (DBBM) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG). Receives: Other: Alveolar ridge preservation |
| Alveolar ridge preservation without bone grafting covered with socket sealing mean | Experimental | Alveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG). Receives: Other: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical dimensional alterations of the alveolar ridge, after tooth extraction.
Assessment of the alteration of the alveolar ridge height after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Measured: 4 months
Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.
Assessment of the alteration of the alveolar ridge width after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Mar 2017
- Primary completion20 Dec 2019
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iosif El-Sioufi, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934813
- Sponsor's protocol ID
- Ethical committe No324
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Sioufi I, Oikonomou I, Koletsi D, Bobetsis YA, Madianos PN, Vassilopoulos S. Clinical evaluation of different alveolar ridge preservation techniques after tooth extraction: a randomized clinical trial. Clin Oral Investig. 2023 Aug;27(8):4471-4480. doi: 10.1007/s00784-023-05068-1. Epub 2023 May 25.
PubMed 37227497
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Alveolar Ridge Preservation Techniques After Tooth Extraction: a Single- Center, Triple Blinded Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04934813
- Acronym / sponsor ID
- Ethical committe No324
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 22 Jun 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 the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.
Detailed description
Thrirty-six patients were randomly assigned in four treatment groups: A) freeze-dried bone allograft (FDBA) covered with collagen sponge (CS), B) FDBA covered with free gingival graft (FGG), C) demineralized bovine bone mineral xenograft (DBBM) covered with FGG and D) FGG without socket grafting. Clinical measurements were performed immediately after tooth extraction and 4 months later. The related outcomes pertained to both vertical and horizontal assessment of bone loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation with particulated allograft covered with collagen sponge. | Experimental | Other: Alveolar ridge preservationAlveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with collagen sponge (CS). |
| Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch | Experimental | Other: Alveolar ridge preservationAlveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG). |
| Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch | Experimental | Other: Alveolar ridge preservationAlveolar ridge preservation after tooth extraction. Demineralized bovine bone mineral xenograft (DBBM) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG). |
| Alveolar ridge preservation without bone grafting covered with socket sealing mean | Experimental | Other: Alveolar ridge preservationAlveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- systematically healthy patients
- non-smokers
- no use of antibiotics for the last 3 months
- presence of a non-restorable single-rooted tooth in the maxilla.
Key exclusion criteria (1 listed)
- Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
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 |
|---|---|---|
| Alveolar ridge preservationapplication of different bone graft and sealing means after tooth extraction | Other | Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch, Alveolar ridge preservation with particulated allograft covered with collagen sponge., Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch, Alveolar ridge preservation without bone grafting covered with socket sealing mean |
Primary outcome
Vertical dimensional alterations of the alveolar ridge, after tooth extraction.
Time frame: 4 months
Assessment of the alteration of the alveolar ridge height after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.
Time frame: 4 months
Assessment of the alteration of the alveolar ridge width after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 37227497El-Sioufi I, Oikonomou I, Koletsi D, Bobetsis YA, Madianos PN, Vassilopoulos S. Clinical evaluation of different alveolar ridge preservation techniques after tooth extraction: a randomized clinical trial. Clin Oral Investig. 2023 Aug;27(8):4471-4480. doi: 10.1007/s00784-023-05068-1. Epub 2023 May 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Alveolar Bone Loss, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 2021. 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 Greece. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertical dimensional alterations of the alveolar ridge, after tooth extraction. (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT04934813, which also lists 1 linked publication.
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 22 Jun 2021.