Bleeding on ProbingSIMO/TIMONCT06599450
Single vs. Two Implants for Mandibular Overdentures
A study testing Root form dental implant in people with Bleeding on Probing and Alveolar Bone Loss, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Bleeding on Probing, Alveolar Bone Loss, Mastication
- What is being tested?
- Root form dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Jan 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 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a class I Maxillo-mandibular jaw relationship
- patients with residual ridges had normal morphology, were free from severe bony undercuts or flabby tissue, and were covered by firm mucoperiosteum.
- A cone beam CT of the lower arch was made to detect the presence of pathological lesions, remaining roots, or impacted teeth in the arch and evaluate both bone quality and quantity, especially in the area of interest
Who cannot join
- patients with current chemotherapy or radiotherapy, bleeding disorders, uncontrolled diabetes
- patients with a history of drug therapy that interferes with bone resorption or deposition (e.g., the prolonged use of glucocorticoids, antiresorptive medications, selective serotonin reuptake inhibitors, and proton-pump inhibitors),
- Those with any physical reasons that could affect follow-up, psychiatric problems, heavy smokers, drug or alcohol addicts, immunocompromised patients, abnormal jaw relationship, inadequate inter arch space.
- patients with temporomandibular disorders and para-functional habits (e.g., bruxing and clenching).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures
This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.
Read the detailed description
This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.
- Being tested
- Root form dental implant
- Medical subject headings
- Alveolar Bone Loss, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root form dental implantDevice
Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture
| Study group | Role | What they receive |
|---|---|---|
| One median implant | Active comparator | One median implant to retain mandibular complete overdenture Receives: Device: Root form dental implant |
| One parasymphyseal implant | Active comparator | One parasymphyseal implant to retain mandibular complete overdenture Receives: Device: Root form dental implant |
| Two implants | Active comparator | Two implants in the intraforaminal distance to retain mandibular complete overdenture Receives: Device: Root form dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the plaque index
The presence and amount of plaque were determined at the four sites around the implant (mesial, distal, buccal, and lingual) and scored from zero to three. Grade 0: No plaque by probing. Grade 1: film of plaque detected by probing. Grade 2: Visible plaque with the naked eye. Grade 3: abundant soft material in the sulcus, mucosal margin, and adjacent implant surface.
Measured: The plaque index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in the pocket depth
The pocket depth was measured by inserting a graduated plastic periodontal probe between the oral sulcular epithelium and the implant with minimal pressure at the midpoint of the four surfaces. The distance from the bottom of the sulcus to the mucosal margin was measured and recorded to the nearest millimeter; the mean of four readings was considered the pocket depth for this group at the chosen time
Measured: The pocket depth was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in the bleeding index
The bleeding index was assessed for the four surfaces while measuring the pocket depth if the bleeding was visible after probing within 20 seconds. It is typically scored as 0 (no bleeding), 1 (bleeding point), 2 (single line of blood), or 3 (heavy or profuse bleeding). The mean of four readings was considered the bleeding index for this group at the chosen time
Measured: The bleeding index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in bone level around implant
Calculating average bone height involves dividing the sum of buccal, lingual, mesial, and distal bone height by 4. The real bone loss can be calculated by subtraction from the implant length
Measured: Immediately after loading, six months, and twelve months later
Change in the masticatory efficiency
The masticatory efficiency was assessed when the patient ate three different types of food (carrot, apple, and banana) with varying degrees of hardness, cut into standardized pieces (1 cm cube each). The collected data included the following measurements: the chewing stroke count before the first swallow, the chewing stroke count until the oral cavity is empty of food, the count of swallows until the oral cavity is empty of food, the time estimated in seconds until the first swallow, and the time estimated in seconds until the oral cavity is empty of food.
Measured: The masticatory efficiency was documented at follow-up visits one month and three months after the overdenture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2021
- Primary completion1 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding on ProbingStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ezzat Ahmed Al-Gazzar, Al-Azhar University
- Investigators
- Ahmed B El-okl, Professor, Study chair, Removable Prosthodontics, Al-Azhar University, Asuit, EGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599450
- Sponsor's protocol ID
- AUAREC20210006-5
- Acronym
- SIMO/TIMO
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures
- ClinicalTrials.gov ID
- NCT06599450
- Acronym / sponsor ID
- SIMO/TIMO / AUAREC20210006-5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Sep 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.
This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.
Detailed description
This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One median implant | Active comparator | Device: Root form dental implantOne median implant to retain mandibular complete overdenture |
| One parasymphyseal implant | Active comparator | Device: Root form dental implantOne parasymphyseal implant to retain mandibular complete overdenture |
| Two implants | Active comparator | Device: Root form dental implantTwo implants in the intraforaminal distance to retain mandibular complete overdenture |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a class I Maxillo-mandibular jaw relationship
- patients with residual ridges had normal morphology, were free from severe bony undercuts or flabby tissue, and were covered by firm mucoperiosteum.
- A cone beam CT of the lower arch was made to detect the presence of pathological lesions, remaining roots, or impacted teeth in the arch and evaluate both bone quality and quantity, especially in the area of interest
Key exclusion criteria (4 listed)
- patients with current chemotherapy or radiotherapy, bleeding disorders, uncontrolled diabetes
- patients with a history of drug therapy that interferes with bone resorption or deposition (e.g., the prolonged use of glucocorticoids, antiresorptive medications, selective serotonin reuptake inhibitors, and proton-pump inhibitors),
- Those with any physical reasons that could affect follow-up, psychiatric problems, heavy smokers, drug or alcohol addicts, immunocompromised patients, abnormal jaw relationship, inadequate inter arch space.
- patients with temporomandibular disorders and para-functional habits (e.g., bruxing and clenching).
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 |
|---|---|---|
| Root form dental implantPlacement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture | Device | One median implant, One parasymphyseal implant, Two implants |
Primary outcome
Change in the plaque index
Time frame: The plaque index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The presence and amount of plaque were determined at the four sites around the implant (mesial, distal, buccal, and lingual) and scored from zero to three. Grade 0: No plaque by probing. Grade 1: film of plaque detected by probing. Grade 2: Visible plaque with the naked eye. Grade 3: abundant soft material in the sulcus, mucosal margin, and adjacent implant surface.
Change in the pocket depth
Time frame: The pocket depth was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The pocket depth was measured by inserting a graduated plastic periodontal probe between the oral sulcular epithelium and the implant with minimal pressure at the midpoint of the four surfaces. The distance from the bottom of the sulcus to the mucosal margin was measured and recorded to the nearest millimeter; the mean of four readings was considered the pocket depth for this group at the chosen time
Change in the bleeding index
Time frame: The bleeding index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
The bleeding index was assessed for the four surfaces while measuring the pocket depth if the bleeding was visible after probing within 20 seconds. It is typically scored as 0 (no bleeding), 1 (bleeding point), 2 (single line of blood), or 3 (heavy or profuse bleeding). The mean of four readings was considered the bleeding index for this group at the chosen time
Change in bone level around implant
Time frame: Immediately after loading, six months, and twelve months later
Calculating average bone height involves dividing the sum of buccal, lingual, mesial, and distal bone height by 4. The real bone loss can be calculated by subtraction from the implant length
Change in the masticatory efficiency
Time frame: The masticatory efficiency was documented at follow-up visits one month and three months after the overdenture insertion
The masticatory efficiency was assessed when the patient ate three different types of food (carrot, apple, and banana) with varying degrees of hardness, cut into standardized pieces (1 cm cube each). The collected data included the following measurements: the chewing stroke count before the first swallow, the chewing stroke count until the oral cavity is empty of food, the count of swallows until the oral cavity is empty of food, the time estimated in seconds until the first swallow, and the time estimated in seconds until the oral cavity is empty of food.
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 19 Sep 2024.
- 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.
Ahmed B El-okl, Professor study chair
Removable Prosthodontics, Al-Azhar University, Asuit, EGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root form dental implant in people with Bleeding on Probing and Alveolar Bone Loss, run by Al-Azhar 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 4 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 19 Sep 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?
Change in the plaque index (time frame: The plaque index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.). The study lists 5 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 19 Sep 2024.