Immediate Implant With LoadingNCT06515509
Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement
A study testing immediate implant placement with or without loading in people with Immediate Implant With Loading, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant With Loading
- What is being tested?
- immediate implant placement with or without loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2023to 16 Jul 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.
- 2. Patients with healthy systemic condition. 3. Patients aged from 20 to 45 years old. 4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014) 5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014) 6. Good oral hygiene.(Wiesner et al., 2010) 7. Accepts one year follow-up period (cooperative patients) Patient provides an informed consent.
- 8. Adequate Inter-arch space for implant placement. 9. Favorable occlusion (no traumatic occlusion)
Who cannot join
- 1. Patients with signs of acute infection related to the area of interest. 2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- 3. Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement in the Maxillary Premolar Area With or Without Loading: A Randomized Controlled Clinical Trial
The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?
- Conditions
- Immediate Implant With Loading
- Being tested
- immediate implant placement with or without loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with or without loadingProcedure or surgery
immediate implant placement with or without loading
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implants with loading | Active comparator | Not described Receives: Procedure: immediate implant placement with or without loading |
| Immediate Implants without loading | Active comparator | Not described Receives: Procedure: immediate implant placement with or without loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of alveolar bone crest
After the implants are placed, a series of digital radiographs are obtained at 0 , 3, and 6 months duration to study the changes in the amount of crestal bone level.
Measured: 6 months
Secondary outcomes (3)
Implant stability
Implant stability quotient (ISQ) values were measured with an Osstell® (Integration Diagnostics AB, Gothenburg, Sweden)
Measured: 6 months
Alveolar bone width
(CBCT) images are used for evaluation of alveolar bone width around all implant sides all over. At 0. 3, 6 month postoperative by using superimposition and subtraction method
Measured: 6 months
post-surgical patient satisfaction
Post-Surgical Patient Satisfaction Questionnaire (PSPSQ) composed of 3 questions is filled by the patient and numerical score is obtained
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start16 Jul 2023
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Immediate Implant With LoadingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Atef Elshahat Attia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515509
- Sponsor's protocol ID
- 15-7-23
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Ekrish AA, Ekram M. A comparative study of the accuracy and reliability of multidetector computed tomography and cone beam computed tomography in the assessment of dental implant site dimensions. Dentomaxillofac Radiol. 2011 Feb;40(2):67-75. doi: 10.1259/dmfr/27546065.
PubMed 21239568Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
PubMed 7246093AlQahtani SM. A novel method of assessment of BMD using CBCT for implant placement: A retrospective study. Medicine (Baltimore). 2023 Jul 7;102(27):e34203. doi: 10.1097/MD.0000000000034203.
PubMed 37417616Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.
PubMed 19515033Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
PubMed 17974108Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.
PubMed 18761580Mantena SR, Sivagami G, Gottumukkala SN. Evaluation of crestal bone loss and stability of immediate functional loading versus immediate non-functional loading of single-mandibular posterior implants: A pilot randomized controlled clinical trial. Dent Res J (Isfahan). 2014 Sep;11(5):585-91.
PubMed 25426151
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement in the Maxillary Premolar Area With or Without Loading: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06515509
- Acronym / sponsor ID
- 15-7-23
- Conditions
- Immediate Implant With Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 23 Jul 2024 (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 this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Implants with loading | Active comparator | Procedure: immediate implant placement with or without loading |
| Immediate Implants without loading | Active comparator | Procedure: immediate implant placement with or without loading |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.
- 2. Patients with healthy systemic condition. 3. Patients aged from 20 to 45 years old. 4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014) 5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014) 6. Good oral hygiene.(Wiesner et al., 2010) 7. Accepts one year follow-up period (cooperative patients) Patient provides an informed consent.
- 8. Adequate Inter-arch space for implant placement. 9. Favorable occlusion (no traumatic occlusion)
Key exclusion criteria (2 listed)
- 1. Patients with signs of acute infection related to the area of interest. 2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- 3. Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.
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 placement with or without loadingimmediate implant placement with or without loading | Procedure or surgery | Immediate Implants with loading, Immediate Implants without loading |
Primary outcome
Height of alveolar bone crest
Time frame: 6 months
After the implants are placed, a series of digital radiographs are obtained at 0 , 3, and 6 months duration to study the changes in the amount of crestal bone level.
3 secondary outcomes
Implant stability
Time frame: 6 months
Alveolar bone width
Time frame: 6 months
post-surgical patient satisfaction
Time frame: 6 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 23 Jul 2024.
- Background: PubMed 21239568Al-Ekrish AA, Ekram M. A comparative study of the accuracy and reliability of multidetector computed tomography and cone beam computed tomography in the assessment of dental implant site dimensions. Dentomaxillofac Radiol. 2011 Feb;40(2):67-75. doi: 10.1259/dmfr/27546065.
- Background: PubMed 7246093Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
- Background: PubMed 37417616AlQahtani SM. A novel method of assessment of BMD using CBCT for implant placement: A retrospective study. Medicine (Baltimore). 2023 Jul 7;102(27):e34203. doi: 10.1097/MD.0000000000034203.
- Background: PubMed 19515033Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.
- Background: PubMed 17974108Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
- Background: PubMed 18761580Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.
- Background: PubMed 25426151Mantena SR, Sivagami G, Gottumukkala SN. Evaluation of crestal bone loss and stability of immediate functional loading versus immediate non-functional loading of single-mandibular posterior implants: A pilot randomized controlled clinical trial. Dent Res J (Isfahan). 2014 Sep;11(5):585-91.
- Individual participant dataSharing planned: Undecided
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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 immediate implant placement with or without loading in people with Immediate Implant With Loading, run by Cairo 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 3 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 23 Jul 2024. 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?
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?
Height of alveolar bone crest (time frame: 6 months). 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 NCT06515509, which also lists 7 linked publications.
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 23 Jul 2024.