Atrophy of Edentulous Alveolar RidgePhase 1/2NCT01399775
Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure
A Phase 1/2 study testing immediate implantation and Delayed implantation in people with Atrophy of Edentulous Alveolar Ridge and Alveolar Ridge Augmentation, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
1. Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation 2. evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Alveolar Ridge, Alveolar Ridge Augmentation
- What is being tested?
- immediate implantation and Delayed implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with hopeless single root tooth and willing for dental implants
- Having no systemic disease
Who cannot join
- Fail to osseointegrate
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Sciences, Dental school
Mashhad, Razavi Khorasan Province, 91735-984
About this study
Official title: Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation
- Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
- evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability
Read the detailed description
24 hopeless single root teeth will be selected. The horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with DFDBA.
Horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.
The vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ).
The primary and secondary stability will be measured using Osstell at baseline and 3-month later.
Twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. All the measurement will be assessed using caliper and CBCT at the time of extraction and 3-month later at the time of implant insertion.
- Being tested
- immediate implantation, Delayed implantation
- Keywords
- Atrophy of Edentulous Alveolar Ridge, Dental Prosthesis, Implant-Supported, Dental Implants, Single-Tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implantationProcedure or surgery
Also called Implant in fresh socket
Immediately after tooth extraction, a dental implant is inserted
Delayed implantationProcedure or surgery
Four months after extraction, a dental implant is inserted and measurements are recorded.
| Study group | Role | What they receive |
|---|---|---|
| immediate implantation | Experimental | Immediately after tooth extraction, dental implant is inserted. Receives: Procedure: immediate implantation |
| Delayed implantation | Other | Four months after extraction, Dental implant is inserted. Receives: Procedure: Delayed implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
dimensional changes
Horizontal dimensions (bucco-linguall) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.
Measured: baseline to 3 months
Secondary outcomes (1)
implant stability
The primary and secondary stability will be measured using osstell at baseline and 3-month later.
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy of Edentulous Alveolar RidgeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Moeintaghavi, Mashhad University of Medical Sciences
- Investigators
- Mehrdad Radvar, DDS., Phd, Study chair, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399775
- Sponsor's protocol ID
- 87703
- Status last verified
- Apr 2015
- First submitted
- 21 Jul 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation
- ClinicalTrials.gov ID
- NCT01399775
- Acronym / sponsor ID
- 87703
- Keywords
- Atrophy of Edentulous Alveolar Ridge, Dental Prosthesis, Implant-Supported, Dental Implants, Single-Tooth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jul 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.
- Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
- evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability
Detailed description
24 hopeless single root teeth will be selected. The horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with DFDBA.
Horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.
The vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ).
The primary and secondary stability will be measured using Osstell at baseline and 3-month later.
Twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. All the measurement will be assessed using caliper and CBCT at the time of extraction and 3-month later at the time of implant insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implantation | Experimental | Procedure: immediate implantationImmediately after tooth extraction, dental implant is inserted. |
| Delayed implantation | Other | Procedure: Delayed implantationFour months after extraction, Dental implant is inserted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hopeless single root tooth and willing for dental implants
- Having no systemic disease
Key exclusion criteria (1 listed)
- Fail to osseointegrate
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 |
|---|---|---|
| immediate implantationAlso: Implant in fresh socketImmediately after tooth extraction, a dental implant is inserted | Procedure or surgery | immediate implantation |
| Delayed implantationFour months after extraction, a dental implant is inserted and measurements are recorded. | Procedure or surgery | Delayed implantation |
Primary outcome
dimensional changes
Time frame: baseline to 3 months
Horizontal dimensions (bucco-linguall) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.
1 secondary outcome
implant stability
Time frame: baseline to 3 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 8 Apr 2015.
Related trials for Atrophy of Edentulous Alveolar Ridge
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Recruiting
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy
Not yet recruitingObservational study
Multicentric Prospective Observational Study of Neodent Implantable Devices of Helix Short System
Edentulism, Dental Implant
Recruiting
Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement
Atrophy of Edentulous Maxillary Alveolar Ridge, Alveolar Bone Atrophy
RecruitingPhase 4
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge
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.
Mehrdad Radvar, DDS., Phd study chair
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 1/2 study testing immediate implantation and Delayed implantation in people with Atrophy of Edentulous Alveolar Ridge and Alveolar Ridge Augmentation, 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 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 8 Apr 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
dimensional changes (time frame: baseline to 3 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 8 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.