Bone LossNCT06165913
The Evaluation of Facial Bone Changes After Early Implant Placement Protocols "Clinically and Radiographically".
A study testing Early implant placement(type II) and Early implant placement (type III) in people with Bone Loss and Dental Implants, run by Tanta University at 1 site in Egypt.
Trial summary
The loss of a single tooth could negatively impact the physiologic occlusion because of the tipping of neighboring teeth and the super-eruption of the opposing teeth. In addition, it compromises the esthetic, especially when anterior teeth are missing, leading to psychological problems such as loss of confidence and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bone Loss, Dental Implants
- What is being tested?
- Early implant placement(type II) and Early implant placement (type III)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2023to Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 20 years old.
- Patients with hopeless tooth in the maxillary anterior premolar region with socket type I indicated for extraction due to failure endodontic treatment, vertical root fracture, …etc.
- Patients in good health with no medical contra-indication that would prevent routine oral surgery.
- Patients with a positive attitude towards oral hygiene
Who cannot join
- Patients with relevant medical conditions that may delay healing or compromise implant osseointegration.
- Presence of risk factors as diabetes or smoking.
- Pregnant or lactating women.
- Absence of buccal bone after tooth extraction.
- Insufficient vertical inter-arch space to accommodate the prostheses.
Trial locations and contacts
1 site in 1 country.
About this study
The loss of a single tooth could negatively impact the physiologic occlusion because of the tipping of neighboring teeth and the super-eruption of the opposing teeth. In addition, it compromises the esthetic, especially when anterior teeth are missing, leading to psychological problems such as loss of confidence and avoidance of smiling in public with a defect in phonetics.
Restoration of the missing tooth is achieved in many ways, including removable dental appliances, fixed dental prostheses and dental implants.
Implant placement is classified into different protocols according to the time of placement in relation to the time of extraction. These different protocols are immediate implant placement (type 1) on the day of extraction; early implant placement (type 2) after 4-8 weeks with soft tissue healing; early implant placement (type 3) after 12-16 weeks with partial bone healing; and delayed dental implant placement (type 4) after complete bone healing at least 6 months after tooth extraction the Aim of the work: to evaluate facial bone changes after early implant placement protocols clinically and radiographically.
Read the detailed description
Dental implant is the most reliable option as it replace the natural tooth without affecting the neighboring teeth and preserve the surrounding tooth structure with better functional performance. Implant placement is classified in different protocols according to the time of placement in relation to time of extraction. These Different protocols are immediate implant placement (type 1) on the day of extraction, early implant placement (type 2) after 4-8 weeks with soft tissue healing, early implant placement (type 3) after 12-16 weeks with partial bone healing and delayed dental implant placement (type 4) after complete bone healing at least after 6 months from tooth extraction.
Early Implant placement (type 2) after 4-8 weeks post extraction that allows soft tissue healing, resolution of local pathology, shorter treatment time, increase soft tissue volume makes it easier to manipulate the surgical flaps and enables flap advancement for primary closure.
Early implant placement (type 3) after 12-16 weeks with partial bone healing allow more implant stability than in type 1 and type 2 implant placement. The soft tissues are usually completely recovered, enabling tension free closure of the flap and improves esthetic outcomes. However, bone remodeling is more advanced. Perimplant defects may still be present, but with partial bone healing they are reduced in dimension.
Aim of the Work:
The evaluation of facial bone changes after early implant placement protocols clinically and radiographically.
- Conditions
- Bone Loss, Dental Implants
- Being tested
- Early implant placement(type II), Early implant placement (type III)
- Keywords
- facial bone loss, early implant placement, bone changes after implant
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early implant placement(type II)Procedure or surgery
in group 1, Tooth extraction will be performed with care to preserve alveolar bone walls. After 4-8 weeks from tooth extraction, dental implant will be placed
Early implant placement (type III)Procedure or surgery
in group 2, Tooth extraction will be performed with care to preserve alveolar bone walls. After 12-16 weeks from tooth extraction, dental implant will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Group (1): Early implant placement(type II) group. | Experimental | Patients will be scheduled for tooth extraction then performing implant placement between 4-8 weeks later after soft tissue healing. Receives: Procedure: Early implant placement(type II) |
| Group (2): Early implant placement (type III) group. | Experimental | Patients will be scheduled for tooth extraction and performing implant placement between 12-16 weeks with partial bone healing. Receives: Procedure: Early implant placement (type III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pocket depth will be measured by mm
the effect of type of implant placement in G1and G2 will be evaluated clinically regarding pocket depth. pocket depth will be measured by mm these measurements will be done after 6 and 12 months post dental implant placement.
Measured: 6-12 months
primary radiographical outcome
the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss.
CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement:
- Vertical facial bone length (VFBL) is the perpendicular distance from implant platform (0) to most coronal point of the facial bone.
Measured: 12 months
primary radiographical outcome
the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss.
CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement:
- Horizontal facial bone thickness (HFBT) is the thickness of facial bone in anterior-posterior direction in respect to implant fixture: Horizontal bone thickness will be measured at margin of platform level 0,1,2and3 mm from implant platform level.
Measured: 12 months
Secondary outcomes (3)
The Plaque index
The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Plaque index
Measured: 6-12 months
The Bleeding on probing
The effect of type of implant placement in G1and G2 will be evaluated clinically regarding Bleeding on probing.
Measured: 6-12 months
Horizontal bone thickness will be measured at the middle and apex of implant fixture
the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss.
CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement:
- Horizontal bone thickness will be measured at the middle and apex of implant fixture.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start30 May 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Abdelkader Radwan, Tanta University
- Investigators
- Rehab F Ghouraba, PHD, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165913
- Sponsor's protocol ID
- 1993
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Facial Bone Changes After Early Implant Placement Protocols "Clinically and Radiographically".
- ClinicalTrials.gov ID
- NCT06165913
- Acronym / sponsor ID
- 1993
- Conditions
- Bone Loss, Dental Implants
- Keywords
- facial bone loss, early implant placement, bone changes after implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Dec 2023 (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 loss of a single tooth could negatively impact the physiologic occlusion because of the tipping of neighboring teeth and the super-eruption of the opposing teeth. In addition, it compromises the esthetic, especially when anterior teeth are missing, leading to psychological problems such as loss of confidence and avoidance of smiling in public with a defect in phonetics.
Restoration of the missing tooth is achieved in many ways, including removable dental appliances, fixed dental prostheses and dental implants.
Implant placement is classified into different protocols according to the time of placement in relation to the time of extraction. These different protocols are immediate implant placement (type 1) on the day of extraction; early implant placement (type 2) after 4-8 weeks with soft tissue healing; early implant placement (type 3) after 12-16 weeks with partial bone healing; and delayed dental implant placement (type 4) after complete bone healing at least 6 months after tooth extraction the Aim of the work: to evaluate facial bone changes after early implant placement protocols clinically and radiographically.
Detailed description
Dental implant is the most reliable option as it replace the natural tooth without affecting the neighboring teeth and preserve the surrounding tooth structure with better functional performance. Implant placement is classified in different protocols according to the time of placement in relation to time of extraction. These Different protocols are immediate implant placement (type 1) on the day of extraction, early implant placement (type 2) after 4-8 weeks with soft tissue healing, early implant placement (type 3) after 12-16 weeks with partial bone healing and delayed dental implant placement (type 4) after complete bone healing at least after 6 months from tooth extraction.
Early Implant placement (type 2) after 4-8 weeks post extraction that allows soft tissue healing, resolution of local pathology, shorter treatment time, increase soft tissue volume makes it easier to manipulate the surgical flaps and enables flap advancement for primary closure.
Early implant placement (type 3) after 12-16 weeks with partial bone healing allow more implant stability than in type 1 and type 2 implant placement. The soft tissues are usually completely recovered, enabling tension free closure of the flap and improves esthetic outcomes. However, bone remodeling is more advanced. Perimplant defects may still be present, but with partial bone healing they are reduced in dimension.
Aim of the Work:
The evaluation of facial bone changes after early implant placement protocols clinically and radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1): Early implant placement(type II) group. | Experimental | Procedure: Early implant placement(type II)Patients will be scheduled for tooth extraction then performing implant placement between 4-8 weeks later after soft tissue healing. |
| Group (2): Early implant placement (type III) group. | Experimental | Procedure: Early implant placement (type III)Patients will be scheduled for tooth extraction and performing implant placement between 12-16 weeks with partial bone healing. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above 20 years old.
- Patients with hopeless tooth in the maxillary anterior premolar region with socket type I indicated for extraction due to failure endodontic treatment, vertical root fracture, …etc.
- Patients in good health with no medical contra-indication that would prevent routine oral surgery.
- Patients with a positive attitude towards oral hygiene
Key exclusion criteria (5 listed)
- Patients with relevant medical conditions that may delay healing or compromise implant osseointegration.
- Presence of risk factors as diabetes or smoking.
- Pregnant or lactating women.
- Absence of buccal bone after tooth extraction.
- Insufficient vertical inter-arch space to accommodate the prostheses.
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 |
|---|---|---|
| Early implant placement(type II)in group 1, Tooth extraction will be performed with care to preserve alveolar bone walls. After 4-8 weeks from tooth extraction, dental implant will be placed | Procedure or surgery | Group (1): Early implant placement(type II) group. |
| Early implant placement (type III)in group 2, Tooth extraction will be performed with care to preserve alveolar bone walls. After 12-16 weeks from tooth extraction, dental implant will be placed. | Procedure or surgery | Group (2): Early implant placement (type III) group. |
Primary outcome
The pocket depth will be measured by mm
Time frame: 6-12 months
the effect of type of implant placement in G1and G2 will be evaluated clinically regarding pocket depth. pocket depth will be measured by mm these measurements will be done after 6 and 12 months post dental implant placement.
primary radiographical outcome
Time frame: 12 months
the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss. CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement: A. Vertical facial bone length (VFBL) is the perpendicular distance from implant platform (0) to most coronal point of the facial bone.
primary radiographical outcome
Time frame: 12 months
the effect of type of implant placement in G1and G2 will be evaluated radiographically by cone beam computed tomography (CBCT) regarding facial bone loss. CBCT will be taken 24 hours after surgery (base line) and 12 months from surgery to obtain following measurement: B. Horizontal facial bone thickness (HFBT) is the thickness of facial bone in anterior-posterior direction in respect to implant fixture: Horizontal bone thickness will be measured at margin of platform level 0,1,2and3 mm from implant platform level.
3 secondary outcomes
The Plaque index
Time frame: 6-12 months
The Bleeding on probing
Time frame: 6-12 months
Horizontal bone thickness will be measured at the middle and apex of implant fixture
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
Rehab F Ghouraba, PHD study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early implant placement(type II) and Early implant placement (type III) in people with Bone Loss and Dental Implants, run by Tanta University at 1 site in Egypt.
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 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 12 Dec 2023. 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 Egypt. 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?
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?
The pocket depth will be measured by mm (time frame: 6-12 months). The study lists 3 primary outcomes in all. 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 12 Dec 2023.