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Alveolar Ridge AugmentationNCT06265467

Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed .

A study testing Closed Sinus Elevation and Open Sinus Elevation in people with Alveolar Ridge Augmentation and Sinus Floor Augmentation, run by Misr International University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Closed Sinus Elevation and Open Sinus Elevation
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
1 Jan 2022to 1 Jul 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
  • Adults above the age of 18.
  • Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
  • Good oral hygiene.
  • Patient accepts to sign an informed consent.

Who cannot join

  • Smokers (more than 10 cigarettes per day).
  • Medically compromised patients.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with untreated active periodontal diseases.
  • Patients with parafunctional habits.
  • Acute or chronic sinusitis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Suez Canal University

    Ismailia, 41522

Other trials in Egypt

About this study

Official title: Assessment of Implants Placed Simultaneously With Maxillary Sinus Bone Augmentation Using Two Different Sinus Elevation Techniques: A Randomized Control Clinical Trial

A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.

Read the detailed description

Following extraction of posterior teeth in the maxillary arch, maxillary sinus pneumatization may pause a difficulty for dental implant placement. This difficulty may be overcome by maxillary sinus elevation with or without bone grafting or the use of short implants. Yet the literature available does not give conclusive answers as to what is the best approach for each clinical situation.

Aim of this study is to evaluate implants placed simultaneously with maxillary sinus bone augmentation using two different sinus floor elevation techniques. Null Hypothesis: There is no statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.

Alternative Hypothesis: There is statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.

Thirty implants in patients having posterior edentulism with maxillary sinus pneumatization were studied. All patients were be randomly allocated into two groups, group 1 (test group) had dental implants placed after crestal approach for sinus elevation, while group 2 (control group) had dental implants placed after lateral approach for maxillary sinus elevation. Both groups received allogenic bone grafts in the elevated sites. To assess implant stability, a resonance frequency analysis (RFA) device was used, for each implant the implant stability quotient (ISQ) values was measured on four sites over the implant. Mean values were calculated for each implant from the four recorded values. ISQ values were recorded immediately post-implant insertion, 9 months (after delivery of the final prosthesis) and at 12 post- operative. Cone Beam Computed Tomography (CBCT)s were made at 6 and 12 months post-operative to evaluate the radiographic bone changes in vertical dimension of bone height gained around each implant.

Steps of the clinical Procedures:

  1. Clinical and radiographic evaluation:
  2. Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
  3. A preoperative CBCT was performed for each patient prior to the surgery. Evaluation of available bone height and bucco-palatal bone width. Suitable implant length and diameter will be determined as well.
  4. Random allocation: The patients were divided into two groups with a random allocation sequence generator.
  5. Surgical procedure: After administration of local anesthesia, the allocation was revealed, for the test group, a full thickness flap was elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy was prepared following standard implant system protocol preparation of the osteotomy. Drilling was done gently till reaching 0-1mm from the sinus floor, then in fracture of the sinus floor was done using osteotomes followed by bone grafting to raise the sinus floor from 3-5 mm and finally implant placement. For the control group, a full-thickness flap was elevated at the edentulous site with two vertical releasing incisions extending to the vestibule for better reflection and exposure to the lateral wall of the sinus. The lateral antrostomy was prepared in the lateral sinus wall using rotary bur no. 8 to provide adequate access to remove the thin to thick cortical bone and to expose the thin sinus membrane. The membrane was elevated across the sinus floor and up the medial wall and this elevation extended anteriorly-posteriorly to provide the exposed sinus floor. Drilling was done gently till reaching 0-1mm from the sinus floor, then implant placement and bone grafting took place. Primary stability of the implant was measured by rotational insertion torque value, to be ≥30 Nano centimeter(25). A resorbable collagen membrane was placed over the window preparation in the lateral approach to prevent the flap tissue from entering inside the antrostomy and the influencing the osseointegration process. Primary closure of the flap was achieved.
  6. Postoperative Care:

Appropriate postoperative care was given to the patients and proper medications prescribed to them.

Patient self-care instructions:

  • Application of an ice pack to the treated area for the first 24 hours will be instructed.
  • The patients will be instructed to gently brush the operated area after two weeks with a soft brush.
  • In case of emergency; severe pain and bleeding, the patient will be presented to the clinic.
  • Patients will be recalled after two weeks for suture removal and every month for supportive periodontal therapy and recording of outcome variables at six,nine and twelve months.

After 9 months of the implant placement, stage II will be performed, 2 weeks later, impressions will be taken as regular for the prosthetic crowns fabrication. All crowns will be temporary cemented to allow an easy access to the implant platform for the follow-up RFA measurements.

Being tested
Closed Sinus Elevation, Open Sinus Elevation
Keywords
Dental Implant, Maxillary Sinus Augmentation, Sinus Elevation, Open Sinus Elevation, Closed Sinus Elevation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed Sinus ElevationProcedure or surgery

    Also called Crestal approach to elevate the maxillary sinus membrane, Osteotome Technique

    using a unique design of osteotomes to crestally elevate the Schneiderian membrane of the maxillary sinus floor

  • Open Sinus ElevationProcedure or surgery

    Also called Lateral Approach to elevate the maxillary sinus Membrane

    using a unique design of sinus elevators to laterally elevate the Schneiderian membrane of the maxillary sinus floor

Study groups in NCT06265467
Study groupRoleWhat they receive
Test Group- Closed Sinus elevationExperimentalMaxillary sinus floor elevation using osteotomes through a crestal approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement.
Receives: Procedure: Closed Sinus Elevation
Control Group- Open sinus elevationActive comparatorMaxillary sinus floor elevation using sinus elevation tools through a lateral window approach. Followed by bone grafting using allogenic bone graft and simultaneous dental implant placement.
Receives: Procedure: Open Sinus Elevation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Stability

    Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA

    Measured: immediate postoperative- 9 months- 12 months

Secondary outcomes (1)
  1. Radiographic bone gain

    CBCT linear measurements using the ruler tool in the CBCT software to assess radiographic vertical bone height gain in millimeter in both techniques

    Measured: immediate post-operative- 6 months-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Jan 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Jul 2023

Resources

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
Model description
Parallel Assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06265467
Sponsor's protocol ID
28909108800228
Status last verified
Feb 2024
First submitted
9 Feb 2024
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Closed Sinus Elevation and Open Sinus Elevation in people with Alveolar Ridge Augmentation and Sinus Floor Augmentation, run by Misr International 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 5 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: finished, as of the sponsor's last update on 20 Feb 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?

Implant Stability (time frame: immediate postoperative- 9 months- 12 months). 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 20 Feb 2024.

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