Missed Upper Posterior TeethNCT05613335
Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone With Simultaneous Implant Insertion.
A study testing Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement and Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement in people with Missed Upper Posterior Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Missed Upper Posterior Teeth
- What is being tested?
- Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement and Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2020to 10 Nov 2022
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a) Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.
- Patients free from any systemic disease
Who cannot join
- 1) Patients with systemic disease that prevent surgical intervention or bone healing.
- 2) Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study
prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.
Read the detailed description
The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.
- Conditions
- Missed Upper Posterior Teeth
- Being tested
- Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement, Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement
- Keywords
- Crestal sinus lift, Autologous fibrin glue, Sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placementProcedure or surgery
Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement
Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placementProcedure or surgery
Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| fibrin glue group | Experimental | Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement Receives: Procedure: Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement |
| sticky bone group | Experimental | Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement Receives: Procedure: Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability.
6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.
Measured: 3 months
Bleeding
Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI).
- Score 0; no bleeding when a periodontal probe was passed along the gingival margin adjacent to the implant.
- Score 1; isolated bleeding visible spot.
- Score 2; a confluent red line on the gingival margin was formed by blood.
- Score 3; heavy or profuse bleeding is present.
Measured: 3 months
Radiographic evaluation
Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site.
- Implant protrusion (IP):measured as the distance from the sinus floor to implant apex.
- Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor).
- Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).
Measured: immediate postoperative
Secondary outcomes (3)
implant stability
implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability.
6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.
Measured: 6 months
Bleeding
Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI).
Measured: 6 months
Radiographic evaluation
Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site.
- Implant protrusion (IP):measured as the distance from the sinus floor to implant apex.
- Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor).
- Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).
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 posted14 Nov 2022
- Study start18 Oct 2020
- Primary completion10 Feb 2022
- Study completion10 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed Upper Posterior TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613335
- Sponsor's protocol ID
- M02150620
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study
- ClinicalTrials.gov ID
- NCT05613335
- Acronym / sponsor ID
- M02150620
- Conditions
- Missed Upper Posterior Teeth
- Keywords
- Crestal sinus lift, Autologous fibrin glue, Sticky bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Nov 2022 (estimated)
- First posted
- 14 Nov 2022 (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.
prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.
Detailed description
The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibrin glue group | Experimental | Procedure: Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placementMaxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement |
| sticky bone group | Experimental | Procedure: Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placementMaxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a) Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.
- Patients free from any systemic disease
Key exclusion criteria (2 listed)
- 1) Patients with systemic disease that prevent surgical intervention or bone healing.
- 2) Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.
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 |
|---|---|---|
| Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placementMaxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement | Procedure or surgery | fibrin glue group |
| Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placementMaxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement | Procedure or surgery | sticky bone group |
Primary outcome
Implant stability
Time frame: 3 months
implant stability using The Ostell ISQ scale: The ISQ scale ranges from 0 to 100 that measures implant stability. The values less than 60 indicate low implant stability; values from 60 to 69 indicate medium stability where values between 70 and 79 indicate high stability. 6 implants from each group will be assessed regarding implant stability at 3 months post-operative using this ISQ scale to determine implant stability and data will be analyzed statistically for significance.
Bleeding
Time frame: 3 months
Peri-implant mucosal bleeding will be graded using criteria of modified sulcus bleeding index (mBI). * Score 0; no bleeding when a periodontal probe was passed along the gingival margin adjacent to the implant. * Score 1; isolated bleeding visible spot. * Score 2; a confluent red line on the gingival margin was formed by blood. * Score 3; heavy or profuse bleeding is present.
Radiographic evaluation
Time frame: immediate postoperative
Cone beam computed tomography scan will be taken at preoperative visit to assess:Residual bone height (RBH) which is the distance from the alveolar crest to the floor of the maxillary sinus at the intended implant placement site. * Implant protrusion (IP):measured as the distance from the sinus floor to implant apex. * Graft height apically (GHa):the distance fom implant apex to the highest level of the grafting material (the new sinus floor). * Grafted sinus height (GSH):the distance from the original sinus floor to the new sinus floor which is the implant protrusion plus the graft height beyond the implant apex (IP +GHa).
3 secondary outcomes
implant stability
Time frame: 6 months
Bleeding
Time frame: 6 months
Radiographic evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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 Maxillary sinus augmentation using autologous fibrin glue with simultaneous implant placement and Maxillary sinus augmentation using mixture of autologous fibrin glue with bone graft with simultaneous implant placement in people with Missed Upper Posterior Teeth, run by Mansoura 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 2 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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?
Implant stability (time frame: 3 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 14 Nov 2022.