Bone LossNCT06666595
Short Implant Versus Crestal Standard Length Implant to Retain Class 1 Removable Partial Denture.
A study testing Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. in people with Bone Loss and Partial Edentulism Class 1, run by Menoufia University at 1 site in Egypt.
Trial summary
Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Partial Edentulism Class 1
- What is being tested?
- Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.
- 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
- 4 Jan 2021to 1 Aug 2025
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients aged 50 years or older with class 1 RPD with missing mandibular molars at least and complaining from instability of the prosthesis were recruited.
- Medical history revealed no contraindication to implant therapy.
- Patients have an amount of bone nearly equal to 8 mm length above the inferior alveolar canal to receive a 6 mm short implant with 2 mm subcrestal to the bone level with sufficient bone width ≥ 8mm on one side and an amount of bone equal to or more than 8 mm to receive a standard-length implant of 7.5, 9, or 10.5 mm placed at crestal bone level with sufficient bone width ≥ 8mm on the contralateral side which was examined by CBCT.
Who cannot join
- Presence of active infection or inflammation in the areas intended for implant placement; *systemic diseases such as diabetes.
- Pregnant and lactating patients.
- Habit of severe bruxism or clenching.
- Treatment with therapeutic radiation to the head within the past 12 months.
- Treatment with bisphosphonate within the past 12 months.
- More than 10 cigarettes/day smoking habit.
Trial locations and contacts
1 site in 1 country.
Mohamed T. Khater, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Mohammed A. El-Sawy
Al Mansurah, 12345
Mohamed A. El-Sawy, PhD, 161314522, Dr_sawy@windowslive.com
Mohamed T. Khater, PhD, mohamed.tarek67@dent.menofia.edu.eg
About this study
Official title: Clinical Outcome of Subcrestal Short Implant Versus Crestal Standard Length Implant to Retain Kennedy Class 1 Removable Partial Denture: A Split-mouth Study
Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD).
Read the detailed description
30 individuals with at least 2 adjacent missing teeth bilaterally were included.to support class Ι RPD with conventional loading protocol were chosen for this research. Each participant received 2 implants in a split mouth design, one side received 1 subcrestal short implant and the contralateral side crestal standard length implant. Plaque index (PI), bleeding on probing (BOP), probing depth (PD), radiographic crestal bone level (CBL) and implant survival rate were evaluated. at implant placement (T0), restoration delivery (T1), and 3-year follow-up after loading (T2). MBL was calculated as the change in distance from the implant-abutment interface to the first radiographically visible bone-implant contact. A repeated-measures mixed ANOVA followed by a paired Student's t-test with the Bonferroni correction was used for statistical analysis. p < 0.05 was considered statistically significant
- Conditions
- Bone Loss, Partial Edentulism Class 1
- Being tested
- Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.
- 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.
Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.Procedure or surgery
Placement of titanium dental implant to retain and support Kennedy class 1 removable partial denture (RPD).The implant fuses with the bone through a process called osseointegration.
| Study group | Role | What they receive |
|---|---|---|
| Subcrestal short implant | Active comparator | Evaluation the amount of bone loss after one, two, and three years of function. Receives: Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. |
| crestal standard length implant | Active comparator | Evaluation the amount of bone loss after one, two, and three years of function. Receives: Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone loss
Evaluation of crestal bone loss around implants will be performed by periapical digital radiograph using parallel technique to avoid distortion or elongation to the image.
Measured: 3 years
Secondary outcomes (2)
Plaque index (PI)
Evaluation of PI around implants were assessed by using a numerical recording of BI (present = 1; absent = 0), PI (present = 1; absent = 0), as well as PD. With the use of a plastic periodontal probe (Hu-Friedy, Chicago, Illinois).
Measured: 3 years
Bleeding on probing (BOP)
Evaluation of BOP around implants were assessed by using a numerical recording of BOP (present = 1; absent = 0), PI (present = 1; absent = 0), as well as PD. With the use of a plastic periodontal probe (Hu-Friedy, Chicago, Illinois).
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 posted30 Oct 2024
- Study start4 Jan 2021
- Primary completion20 Apr 2025 (estimated)
- Study completion1 Aug 2025 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666595
- Sponsor's protocol ID
- ADMNF-00701124
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Subcrestal Short Implant Versus Crestal Standard Length Implant to Retain Kennedy Class 1 Removable Partial Denture: A Split-mouth Study
- ClinicalTrials.gov ID
- NCT06666595
- Acronym / sponsor ID
- ADMNF-00701124
- Conditions
- Bone Loss, Partial Edentulism Class 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Oct 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.
Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD).
Detailed description
30 individuals with at least 2 adjacent missing teeth bilaterally were included.to support class Ι RPD with conventional loading protocol were chosen for this research. Each participant received 2 implants in a split mouth design, one side received 1 subcrestal short implant and the contralateral side crestal standard length implant. Plaque index (PI), bleeding on probing (BOP), probing depth (PD), radiographic crestal bone level (CBL) and implant survival rate were evaluated. at implant placement (T0), restoration delivery (T1), and 3-year follow-up after loading (T2). MBL was calculated as the change in distance from the implant-abutment interface to the first radiographically visible bone-implant contact. A repeated-measures mixed ANOVA followed by a paired Student's t-test with the Bonferroni correction was used for statistical analysis. p < 0.05 was considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcrestal short implant | Active comparator | Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.Evaluation the amount of bone loss after one, two, and three years of function. |
| crestal standard length implant | Active comparator | Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.Evaluation the amount of bone loss after one, two, and three years of function. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients aged 50 years or older with class 1 RPD with missing mandibular molars at least and complaining from instability of the prosthesis were recruited.
- Medical history revealed no contraindication to implant therapy.
- Patients have an amount of bone nearly equal to 8 mm length above the inferior alveolar canal to receive a 6 mm short implant with 2 mm subcrestal to the bone level with sufficient bone width ≥ 8mm on one side and an amount of bone equal to or more than 8 mm to receive a standard-length implant of 7.5, 9, or 10.5 mm placed at crestal bone level with sufficient bone width ≥ 8mm on the contralateral side which was examined by CBCT.
Key exclusion criteria (6 listed)
- Presence of active infection or inflammation in the areas intended for implant placement; *systemic diseases such as diabetes.
- Pregnant and lactating patients.
- Habit of severe bruxism or clenching.
- Treatment with therapeutic radiation to the head within the past 12 months.
- Treatment with bisphosphonate within the past 12 months.
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 |
|---|---|---|
| Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.Placement of titanium dental implant to retain and support Kennedy class 1 removable partial denture (RPD).The implant fuses with the bone through a process called osseointegration. | Procedure or surgery | Subcrestal short implant, crestal standard length implant |
Primary outcome
Bone loss
Time frame: 3 years
Evaluation of crestal bone loss around implants will be performed by periapical digital radiograph using parallel technique to avoid distortion or elongation to the image.
2 secondary outcomes
Plaque index (PI)
Time frame: 3 years
Bleeding on probing (BOP)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No. Up on reasonable request from 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.
Mohamed T. Khater, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis. in people with Bone Loss and Partial Edentulism Class 1, 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 3 inclusion and 6 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 30 Oct 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. El-Sawy, PhD (01061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone loss (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 30 Oct 2024.