Alveolar Bone AtrophyPhase 2NCT01268982
Effect of Socket Preservation Procedure on Dimensional Changes of the Ridge, and Its Efficacy.
A Phase 2 study testing socket preservation in people with Alveolar Bone Atrophy, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
In this study, the investigators will evaluate the dimensional changes of alveolar bone in the preserved sites in comparison with extraction only conventional healed sockets, as well. 1. Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction. 2. Read more about this study
- Who is it for?
- Ages 19 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Atrophy
- What is being tested?
- socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2
- 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 19 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-molar hopeless teeth
- lack of bone volume for ideal implant placement
Who cannot join
- Patient's un-wiliness for involvement in the project
- contraindication of surgery due to medically-related problems
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 91735-984
About this study
Official title: Dimensional Changes of the Alveolar Ridge Contour After Socket Preservation, Stability of Implants Placed, and Histological Evaluation of Newly Formed Bone at These Sites.
In this study, the investigators will evaluate the dimensional changes of alveolar bone in the preserved sites in comparison with extraction only conventional healed sockets, as well.
- Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction.
- Evaluation the stability of implants placed at the preserved sockets.
- Histological evaluation of newly formed bone at the socket preserved sites in comparison with extracted only healed sites.
Read the detailed description
Nineteen systematically healthy patients (10 female and 9 male; mean age 38 years old; range 19-57) providing 32 hopeless non-molar teeth were selected and divided into 2 treatment groups: In the test group, following tooth extraction, for 16 sockets (9sockets from 5 female and 7 sockets from 5 male patients) soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket) will be determined using a caliper and a template. All sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. Then an acid-etch bridge will be applied for the sites, both to avoid the movement of adjacent teeth to the empty space \& also for patients esthetics. 6 months following the procedure, the soft and hard tissue in all the sites will be measured again as it was mentioned previously, plus the measurements gained from CBCT radiographs.
Besides, biopsy will be harvested from some of the preserved sites that has enough width with the use of trephine bur no.3 and it was sent for histological evaluation. Subsequently, Implants will be installed in the preserved sites and the implant stability will be measured with the help of Ostell device. The stability will be measured after 4 month following implant insertion with the same device while the implant undergoes the implant exposure procedure.
In control group, 16 sockets (9 sockets from 5 female, and 7 sockets from 4 male patients) served as unfilled extraction only group. Following extraction, soft and hard tissue measurements (horizontal and vertical ridge dimensions) will be determined with the use of caliper and template.
6month after extraction, CBCT will be taken from the site and at the time of implant installation, the soft and hard tissue in all sites will be measured in vertical and horizontal dimensions. Furthermore, biopsy from some of the healed sockets with enough width will be taken with the use of trephine bur no.3 and it will be sent for histological examination.
- Conditions
- Alveolar Bone Atrophy
- Being tested
- socket preservation
- Keywords
- socket preservation, alveolar ridge augmentation
- 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.
socket preservationProcedure or surgery
Also called DFDBA
sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket
| Study group | Role | What they receive |
|---|---|---|
| preserved socket | Experimental | sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. Receives: Procedure: socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft and hard tissue vertical and horizontal changes
soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket)
Measured: 6 months
Secondary outcomes (1)
histologic evaluation and implant stability measurement
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone AtrophyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamid reza arab, DDS.,Ms., Principal investigator, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268982
- Sponsor's protocol ID
- 88724
- Status last verified
- Jan 2010
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes of the Alveolar Ridge Contour After Socket Preservation, Stability of Implants Placed, and Histological Evaluation of Newly Formed Bone at These Sites.
- ClinicalTrials.gov ID
- NCT01268982
- Acronym / sponsor ID
- 88724
- Conditions
- Alveolar Bone Atrophy
- Keywords
- socket preservation, alveolar ridge augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Jan 2011 (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.
In this study, the investigators will evaluate the dimensional changes of alveolar bone in the preserved sites in comparison with extraction only conventional healed sockets, as well.
- Dimensional changes of the alveolar ridge contour after socket preservation in comparison to conventional tooth extraction.
- Evaluation the stability of implants placed at the preserved sockets.
- Histological evaluation of newly formed bone at the socket preserved sites in comparison with extracted only healed sites.
Detailed description
Nineteen systematically healthy patients (10 female and 9 male; mean age 38 years old; range 19-57) providing 32 hopeless non-molar teeth were selected and divided into 2 treatment groups: In the test group, following tooth extraction, for 16 sockets (9sockets from 5 female and 7 sockets from 5 male patients) soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket) will be determined using a caliper and a template. All sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. Then an acid-etch bridge will be applied for the sites, both to avoid the movement of adjacent teeth to the empty space \& also for patients esthetics. 6 months following the procedure, the soft and hard tissue in all the sites will be measured again as it was mentioned previously, plus the measurements gained from CBCT radiographs.
Besides, biopsy will be harvested from some of the preserved sites that has enough width with the use of trephine bur no.3 and it was sent for histological evaluation. Subsequently, Implants will be installed in the preserved sites and the implant stability will be measured with the help of Ostell device. The stability will be measured after 4 month following implant insertion with the same device while the implant undergoes the implant exposure procedure.
In control group, 16 sockets (9 sockets from 5 female, and 7 sockets from 4 male patients) served as unfilled extraction only group. Following extraction, soft and hard tissue measurements (horizontal and vertical ridge dimensions) will be determined with the use of caliper and template.
6month after extraction, CBCT will be taken from the site and at the time of implant installation, the soft and hard tissue in all sites will be measured in vertical and horizontal dimensions. Furthermore, biopsy from some of the healed sockets with enough width will be taken with the use of trephine bur no.3 and it will be sent for histological examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preserved socket | Experimental | Procedure: socket preservationsockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket. |
Who may qualify
- Ages
- 19 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-molar hopeless teeth
- lack of bone volume for ideal implant placement
Key exclusion criteria (2 listed)
- Patient's un-wiliness for involvement in the project
- contraindication of surgery due to medically-related problems
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 |
|---|---|---|
| socket preservationAlso: DFDBAsockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket | Procedure or surgery | preserved socket |
Primary outcome
soft and hard tissue vertical and horizontal changes
Time frame: 6 months
soft and hard tissue measurements include horizontal (Bucco-Lingual dimensions at 1mm,3mm and 7mm at the mid portion from the line connecting two adjacent CEJs) and vertical ridge dimensions (vertical distance from the line connecting two adjacent CEJs at 8 points: Mid-Buccal, Mid-Lingual, Mesial, Distal, Disto-Buccal, Disto-Lingual, Mesio-Buccal, Mesio-Lingual around the socket)
1 secondary outcome
histologic evaluation and implant stability measurement
Time frame: 10 months
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 4 Jan 2011.
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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.
hamid reza arab, DDS.,Ms. principal investigator
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing socket preservation in people with Alveolar Bone Atrophy, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 2 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 4 Jan 2011. 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 Iran. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
soft and hard tissue vertical and horizontal changes (time frame: 6 months). 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 4 Jan 2011; AzTrials last refreshed its copy on 3 Nov 2026.