Implant ComplicationNCT06447792
Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures
An observational study of Implant Complication and Bone Loss, run by Menoufia University at 1 site in Egypt.
Trial summary
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Implant Complication, Bone Loss
- What is being tested?
- Loading protocol
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 20 Aug 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: People over 25 and less than 50 years
Who may be able to join
- fully dentulous people over 25 who complained of the mobility of 4 mandibular incisor teeth, or partially dentulous people who missed 2 mandibular central incisor teeth and had periodontally affected the neighboring lateral incisor teeth.
- These individuals were subsequently treated with 2 implants supporting FPDs and following a delayed, progressive, or immediate loading protocol
- Class 0 or 1 bone defects after tooth extraction, were only included in the study
- The medical records included data regarding implant type, width, and length, surgical procedure, annual hygienist treatments, radiographs, and implant insertion date
Who cannot join
- had less than 1 years of follow-up, had incomplete restorative or surgical data, had non-diagnostic radiographs, had more or less than 4 unit fixed partial denture
- patients did not present for annual follow-up visits to evaluate oral hygiene measures or treat mechanical or technical complications.
- Individuals with bone defects class 2, 3, 4, or 5 after mandibular lateral incisor tooth extraction were also excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed A. Elsawy
Al Mansurah, 12345
Mohammed A. Elsawy, PhD, 161314522, Dr_sawy@windowslive.com
Mohammed T. khater, PhD, 01003854552, drsawy1989@gmail.com
About this study
Official title: Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures in the Anterior Mandible: A Retrospective Study
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
Read the detailed description
The relationship between implants/ prosthetic components and the surrounding soft and hard tissues is complex and determines the final clinical result. For example, crestal bone resorption, frequently observed following implant placement or following loading, may be related to factors such as the establishment of the biologic width, the macro design of the cervical area of the implant and possible surface treatments, the type of implant/abutment connection, the positioning of the implant in relation to the bone crest, the width of the alveolar ridge, the distance between contiguous implants, the surgical procedure, and the effects of overloading and peri-implantitis. The establishment of the biologic width perse is related to a series of events that results in remodeling of the bone that surrounds the implants, a fact that has been observed by histomorphometry and radiographic analysis.
The aim of the present study was to compare and evaluate the survival rate and crestal bone levels around immediately placed implants in the esthetic zone with delayed, progressive, or immediately placed.
- Conditions
- Implant Complication, Bone Loss
- Being tested
- Loading protocol
- 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.
Loading protocolOther
The prosthetic restoration and functional loading of the dental implant.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | immediately placed implants with a delayed loading protocol. Loading was performed after 3 months. Receives: Other: Loading protocol | |
| Group 2 | immediately placed implants with a progressive loading protocol. Loading was performed after 5 weeks. Receives: Other: Loading protocol | |
| Group 3 | immediately placed implants with an immediate loading protocol. The day of the surgery was also the day of loading. Receives: Other: Loading protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
The implant is present at the follow-up examination but its condition is not specified.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Feb 2024
- Primary completion4 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447792
- Sponsor's protocol ID
- ADMNF-0020524
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For a reasonable reason after contacting the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Rate of 2 Implant-supported Short-span Fixed Partial Dentures in the Anterior Mandible: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06447792
- Acronym / sponsor ID
- ADMNF-0020524
- Conditions
- Implant Complication, Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 4 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 7 Jun 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.
Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
Detailed description
The relationship between implants/ prosthetic components and the surrounding soft and hard tissues is complex and determines the final clinical result. For example, crestal bone resorption, frequently observed following implant placement or following loading, may be related to factors such as the establishment of the biologic width, the macro design of the cervical area of the implant and possible surface treatments, the type of implant/abutment connection, the positioning of the implant in relation to the bone crest, the width of the alveolar ridge, the distance between contiguous implants, the surgical procedure, and the effects of overloading and peri-implantitis. The establishment of the biologic width perse is related to a series of events that results in remodeling of the bone that surrounds the implants, a fact that has been observed by histomorphometry and radiographic analysis.
The aim of the present study was to compare and evaluate the survival rate and crestal bone levels around immediately placed implants in the esthetic zone with delayed, progressive, or immediately placed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Loading protocolimmediately placed implants with a delayed loading protocol. Loading was performed after 3 months. |
| Group 2 | – | Other: Loading protocolimmediately placed implants with a progressive loading protocol. Loading was performed after 5 weeks. |
| Group 3 | – | Other: Loading protocolimmediately placed implants with an immediate loading protocol. The day of the surgery was also the day of loading. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People over 25 and less than 50 years
Key inclusion criteria (4 listed)
- fully dentulous people over 25 who complained of the mobility of 4 mandibular incisor teeth, or partially dentulous people who missed 2 mandibular central incisor teeth and had periodontally affected the neighboring lateral incisor teeth.
- These individuals were subsequently treated with 2 implants supporting FPDs and following a delayed, progressive, or immediate loading protocol
- Class 0 or 1 bone defects after tooth extraction, were only included in the study
- The medical records included data regarding implant type, width, and length, surgical procedure, annual hygienist treatments, radiographs, and implant insertion date
Key exclusion criteria (3 listed)
- had less than 1 years of follow-up, had incomplete restorative or surgical data, had non-diagnostic radiographs, had more or less than 4 unit fixed partial denture
- patients did not present for annual follow-up visits to evaluate oral hygiene measures or treat mechanical or technical complications.
- Individuals with bone defects class 2, 3, 4, or 5 after mandibular lateral incisor tooth extraction were also excluded.
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 |
|---|---|---|
| Loading protocolThe prosthetic restoration and functional loading of the dental implant. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Implant survival
Time frame: 3 years
The implant is present at the follow-up examination but its condition is not specified.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No. For a reasonable reason after contacting the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Complication and Bone Loss, run by Menoufia 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 3 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 7 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. Elsawy, PhD (161314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 3 years). 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 7 Jun 2024.