Badly Decayed Anterior Maxillary TeethNCT03676244
Immediate Implant Placement With Immediate Provisionalization Into Extraction Sockets With Labial Plate Dehiscence Defects Within the Maxillary Esthetic Zone
A study testing immediate implant in defected anterior maxillary esthetic zone in people with Badly Decayed Anterior Maxillary Teeth, run by Cairo University.
Trial summary
Immediate tooth replacement with implants into extraction sockets has become a common clinical procedure regarding implant survival, osseointegration and esthetics. Basically, when there is a labial bone plate loss after extraction 2 stage GBR procedure would be carried out to allow adequate amount of bone formation… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Badly Decayed Anterior Maxillary Teeth
- What is being tested?
- immediate implant in defected anterior maxillary esthetic zone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2018to Sep 2019
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.
- Both sexes.
- No intraoral soft and hard tissue patholog.
- No systemic condition that contraindicate implant placement.
Who cannot join
- General medical or psychiatric contraindications.
- Pregnancy.
- Patients with local or generalized healing limitations.
- Diabetes.
- Smoking type 3 extraction sockets.
- Bruxism or other Para functional habits.
- Compromised soft tissue conditions.
Trial locations and contacts
No sites are listed yet.
About this study
Immediate tooth replacement with implants into extraction sockets has become a common clinical procedure regarding implant survival, osseointegration and esthetics.
Basically, when there is a labial bone plate loss after extraction 2 stage GBR procedure would be carried out to allow adequate amount of bone formation to be reconstructed and receive the dental implant.
The challenge is when there is a partial or complete loss of labial plate of bone resulting from severe trauma or chronic inflammation or vertical fracture affecting the periodontal attachment
Read the detailed description
Elian etal. classified extraction sockets into 3 types: type 1 sockets have labial plate of bone and soft tissue completely intact, type 2: where the soft tissue is intact while there is a dehiscence bony defect indicating partial or complete loss of labial bone plate, and type 3 where a midfacial recession occurred indicating loss of labial bone plate and soft tissue loss.
The clinical outcomes of type 2 sockets reconstructions: Noelken etal. Published survival of 16 implants immediately placed in sockets with
complete loss of labial bone plate and buccal gaps were filled with autogenous bone without using barrier membrane. IN this study immediate implant is to be placed in type 2 sockets filing the gap with a mix of autogenous bone harvested from tuberosity and xenograft in addition to a resorbable collagen membrane lining the socket and healing abutment .
Immediate implant placement concurrent with provisional restoration has been advocated to improve the esthetic restorative outcome for the patients. The success of this procedure depends on many variables including gingival health and morphology, bone dimensions and primary stability of the implants.
Immediate implant placement is most commonly indicated when tooth extraction is due to trauma,endodontic lesion, root fracture, root resorption, root perforation, unfavorable crown to root ratio(not due to periodontal loss and bony walls
of alveolus are still intact.
Contraindications includes presence of active infection, insufficient bone (<3 mm) beyond the tooth socket apex for initial implant stability and wide and/or long gingival recession.
Immediate implant placement even in the aesthetic zone is a literature supported treatment modality with success comparable to alternative placement protocols.3, 4 Immediate placement reduces the number of surgical interventions, shortens time to final restoration, may offer a fixed provisional restoration alternative to a removable interim prosthesis, and may partially support the peri-implant tissues prior to collapse from the extraction socket remodeling. Certain clinical criteria however need to be met in order to achieve a successful treatment outcome, namely: intact extraction socket walls, facial bone residual at ≥ 1 mm, thick gingival biotype, absence of acute infection, and sufficient residual bone at the palatal and apical tooth socket.
Current knowledge suggests that implant placement should be at least 3 to 4 mm in depth from the midfacial free gingival margin and 2 mm palatally from the facial osseous crest.
- Conditions
- Badly Decayed Anterior Maxillary Teeth
- Being tested
- immediate implant in defected anterior maxillary esthetic zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant in defected anterior maxillary esthetic zoneDevice
Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.
Use of GBR (mix of autogenous bone graft and xenograft in combination to absorbable collagen membrane) and healing abutment at the same time of extraction then place implant palatally engaging the side walls of the socket, leaving a buccal gap.
construct custom two-piece screw retained healing abutment then remove custom healing abutment and fit and place the collagen membrane for GBR , the membrane should cover the defect 2 mm circumferentially and extend to the level of free gingival margin, Place bone graft material buccal to the implant surface ,replace custom healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement in anterior esthetic zone | Experimental | extraction of badly broken anterior maxillary teeth with immediate implant placement Receives: Device: immediate implant in defected anterior maxillary esthetic zone |
What is being measured
The primary outcome is the main question the study is designed to answer.
bucco lingual and crestal bone loss
the amount of bone loss will be measured using cone beam computed tomography
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start25 Sep 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Decayed Anterior Maxillary TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merna yehia ghoneim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676244
- Sponsor's protocol ID
- cairoUimplant program
- Status last verified
- Sep 2018
- First submitted
- 16 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Immediate Provisionalization Into Extraction Sockets With Labial Plate Dehiscence Defects Within the Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT03676244
- Acronym / sponsor ID
- cairoUimplant program
- Conditions
- Badly Decayed Anterior Maxillary Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Sep 2018 (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.
Immediate tooth replacement with implants into extraction sockets has become a common clinical procedure regarding implant survival, osseointegration and esthetics.
Basically, when there is a labial bone plate loss after extraction 2 stage GBR procedure would be carried out to allow adequate amount of bone formation to be reconstructed and receive the dental implant.
The challenge is when there is a partial or complete loss of labial plate of bone resulting from severe trauma or chronic inflammation or vertical fracture affecting the periodontal attachment
Detailed description
Elian etal. classified extraction sockets into 3 types: type 1 sockets have labial plate of bone and soft tissue completely intact, type 2: where the soft tissue is intact while there is a dehiscence bony defect indicating partial or complete loss of labial bone plate, and type 3 where a midfacial recession occurred indicating loss of labial bone plate and soft tissue loss.
The clinical outcomes of type 2 sockets reconstructions: Noelken etal. Published survival of 16 implants immediately placed in sockets with
complete loss of labial bone plate and buccal gaps were filled with autogenous bone without using barrier membrane. IN this study immediate implant is to be placed in type 2 sockets filing the gap with a mix of autogenous bone harvested from tuberosity and xenograft in addition to a resorbable collagen membrane lining the socket and healing abutment .
Immediate implant placement concurrent with provisional restoration has been advocated to improve the esthetic restorative outcome for the patients. The success of this procedure depends on many variables including gingival health and morphology, bone dimensions and primary stability of the implants.
Immediate implant placement is most commonly indicated when tooth extraction is due to trauma,endodontic lesion, root fracture, root resorption, root perforation, unfavorable crown to root ratio(not due to periodontal loss and bony walls
of alveolus are still intact.
Contraindications includes presence of active infection, insufficient bone (<3 mm) beyond the tooth socket apex for initial implant stability and wide and/or long gingival recession.
Immediate implant placement even in the aesthetic zone is a literature supported treatment modality with success comparable to alternative placement protocols.3, 4 Immediate placement reduces the number of surgical interventions, shortens time to final restoration, may offer a fixed provisional restoration alternative to a removable interim prosthesis, and may partially support the peri-implant tissues prior to collapse from the extraction socket remodeling. Certain clinical criteria however need to be met in order to achieve a successful treatment outcome, namely: intact extraction socket walls, facial bone residual at ≥ 1 mm, thick gingival biotype, absence of acute infection, and sufficient residual bone at the palatal and apical tooth socket.
Current knowledge suggests that implant placement should be at least 3 to 4 mm in depth from the midfacial free gingival margin and 2 mm palatally from the facial osseous crest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement in anterior esthetic zone | Experimental | Device: immediate implant in defected anterior maxillary esthetic zoneextraction of badly broken anterior maxillary teeth with immediate implant placement |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.
- Both sexes.
- No intraoral soft and hard tissue patholog.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (7 listed)
- General medical or psychiatric contraindications.
- Pregnancy.
- Patients with local or generalized healing limitations.
- Diabetes.
- Smoking type 3 extraction sockets.
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 implant in defected anterior maxillary esthetic zonePatients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate. Use of GBR (mix of autogenous bone graft and xenograft in combination to absorbable collagen membrane) and healing abutment at the same time of extraction then place implant palatally engaging the side walls of the socket, leaving a buccal gap. construct custom two-piece screw retained healing abutment then remove custom healing abutment and fit and place the collagen membrane for GBR , the membrane should cover the defect 2 mm circumferentially and extend to the level of free gingival margin, Place bone graft material buccal to the implant surface ,replace custom healing abutment. | Device | immediate implant placement in anterior esthetic zone |
Primary outcome
bucco lingual and crestal bone loss
Time frame: 6 month
the amount of bone loss will be measured using cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant in defected anterior maxillary esthetic zone in people with Badly Decayed Anterior Maxillary Teeth, run by Cairo University.
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 7 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact merna yehia ghoneim, BDS (01064755460, mirna_yahia.com@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bucco lingual and crestal bone loss (time frame: 6 month). 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 18 Sep 2018.