Sinus; DentalNCT06254378
Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement
A study testing Sinus lifting with allograft and Sinus lifting without graft in people with Sinus; Dental and Implant Complication, run by Cairo University.
Trial summary
Implant placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area. -Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus; Dental, Implant Complication, Surgery-Complications
- What is being tested?
- Sinus lifting with allograft and Sinus lifting without graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Oct 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with missing upper pre molar , molar teeth
- Patients in need of bone grafting of the maxillary sinus to house an implant.
- Patients with residual alveolar crest of at least 3-4mm in height and 5mm in width distal to the canine as measured on CBCT scan
- Patients with adequate inter-arch space
Who cannot join
- Patients suffering from any sinus pathosis.
- Patients who are heavy smokers (>10 cigarettes/day).
- Patient under psychiatric therapy or unrealistic expectations
- Patients of systemic conditions that may interfere with carrying out the surgical procedure.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement
- Severe bruxism or clenching
- Poor oral hygiene (full mouth bleeding on probing and full mouth plaque index >25%)
Trial locations and contacts
No sites are listed yet.
Salma H Abdelaty contact
About this study
Official title: Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement A Randomized Clinical Trial
Implant placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area.
-Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height.
Read the detailed description
Rationale for carrying out the trial:
The research population will be divided into two groups. Group1 will be treated by allograft with immediate implant technique, Group2 will be treated by tenting technique with immediate implant technique. Allograft has been effective in augmenting bone growth and has been proven to be a vital asset in sinus lifting.
- Conditions
- Sinus; Dental, Implant Complication, Surgery-Complications
- Being tested
- Sinus lifting with allograft, Sinus lifting without graft
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus lifting with allograftProcedure or surgery
Participants will receive sinus lifting and allograft with immediate implant in premolar-molar area.
Sinus lifting without graftOther
Also called Tenting technique
Participants will receive sinus lifting with immediate implant in premolar-molar area without graft
| Study group | Role | What they receive |
|---|---|---|
| Sinus lifting without graft (control ) | Active comparator | Patients will receive sinus lifting with immediate implant placement without graft placement. Receives: Other: Sinus lifting without graft |
| Sinus lifting with graft (intervention) | Experimental | Patients will receive sinus lifting with immediate implant and allograft placement. Receives: Procedure: Sinus lifting with allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
implant stability quotient(ISQ) is the evaluation unit set to determine the correct isq<60:low stability isq 60-65 : medium stability isq >70: high stability stability of the implant, this module by means of a resonance frequency analysis (rfa) applied to the bone manages to measure stability on an isq scale from 1 to 100 (khz):
Measured: During the implant placement procedure and after 6 months
Secondary outcomes (1)
Bone hight
Newly formed bone length will be measured on cone beam ct by millimeter
Measured: Before surgery and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sinus; DentalStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Raafat Ahmed Elshikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254378
- Sponsor's protocol ID
- Sinus lifting
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fouad W, Osman A, Atef M, Hakam M. Guided maxillary sinus floor elevation using deproteinized bovine bone versus graftless Schneiderian membrane elevation with simultaneous implant placement: Randomized clinical trial. Clin Implant Dent Relat Res. 2018 Jun;20(3):424-433. doi: 10.1111/cid.12601. Epub 2018 Mar 25.
PubMed 29575547Karagah A, Tabrizi R, Mohammadhosseinzade P, Mirzadeh M, Tofangchiha M, Lajolo C, Patini R. Effect of Sinus Floor Augmentation with Platelet-Rich Fibrin Versus Allogeneic Bone Graft on Stability of One-Stage Dental Implants: A Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Aug 4;19(15):9569. doi: 10.3390/ijerph19159569.
PubMed 35954926
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06254378
- Acronym / sponsor ID
- Sinus lifting
- Conditions
- Sinus; Dental, Implant Complication, Surgery-Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 12 Feb 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 placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area.
-Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height.
Detailed description
Rationale for carrying out the trial:
The research population will be divided into two groups. Group1 will be treated by allograft with immediate implant technique, Group2 will be treated by tenting technique with immediate implant technique. Allograft has been effective in augmenting bone growth and has been proven to be a vital asset in sinus lifting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus lifting without graft (control ) | Active comparator | Other: Sinus lifting without graftPatients will receive sinus lifting with immediate implant placement without graft placement. |
| Sinus lifting with graft (intervention) | Experimental | Procedure: Sinus lifting with allograftPatients will receive sinus lifting with immediate implant and allograft placement. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with missing upper pre molar , molar teeth
- Patients in need of bone grafting of the maxillary sinus to house an implant.
- Patients with residual alveolar crest of at least 3-4mm in height and 5mm in width distal to the canine as measured on CBCT scan
- Patients with adequate inter-arch space
Key exclusion criteria (7 listed)
- Patients suffering from any sinus pathosis.
- Patients who are heavy smokers (>10 cigarettes/day).
- Patient under psychiatric therapy or unrealistic expectations
- Patients of systemic conditions that may interfere with carrying out the surgical procedure.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement
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 |
|---|---|---|
| Sinus lifting with allograftParticipants will receive sinus lifting and allograft with immediate implant in premolar-molar area. | Procedure or surgery | Sinus lifting with graft (intervention) |
| Sinus lifting without graftAlso: Tenting techniqueParticipants will receive sinus lifting with immediate implant in premolar-molar area without graft | Other | Sinus lifting without graft (control ) |
Primary outcome
Implant stability
Time frame: During the implant placement procedure and after 6 months
implant stability quotient(ISQ) is the evaluation unit set to determine the correct isq<60:low stability isq 60-65 : medium stability isq >70: high stability stability of the implant, this module by means of a resonance frequency analysis (rfa) applied to the bone manages to measure stability on an isq scale from 1 to 100 (khz):
1 secondary outcome
Bone hight
Time frame: Before surgery and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 29575547Fouad W, Osman A, Atef M, Hakam M. Guided maxillary sinus floor elevation using deproteinized bovine bone versus graftless Schneiderian membrane elevation with simultaneous implant placement: Randomized clinical trial. Clin Implant Dent Relat Res. 2018 Jun;20(3):424-433. doi: 10.1111/cid.12601. Epub 2018 Mar 25.
- Results publication: PubMed 35954926Karagah A, Tabrizi R, Mohammadhosseinzade P, Mirzadeh M, Tofangchiha M, Lajolo C, Patini R. Effect of Sinus Floor Augmentation with Platelet-Rich Fibrin Versus Allogeneic Bone Graft on Stability of One-Stage Dental Implants: A Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Aug 4;19(15):9569. doi: 10.3390/ijerph19159569.
- 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.
Salma H Abdelaty contact
Questions about this trial
What is this clinical trial studying?
A study testing Sinus lifting with allograft and Sinus lifting without graft in people with Sinus; Dental and Implant Complication, run by Cairo University.
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 7 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Amira R Elshikh, BCS (01068503398, Amira.raafat2512@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: During the implant placement procedure and after 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 NCT06254378, which also lists 2 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 12 Feb 2024.