Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques.

August 23, 2024 updated by: Ahmed Abo El Futtouh, Misr International University

Clinical and Radiographic Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques. A Randomized Controlled Clinical Trial

Statement of the problem: Vertical bone height reduction after extraction in the posterior maxilla complicates the treatment plan. Lateral sinus elevation, crestal sinus elevation, using short implants and different grafting procedures are some of the proposed treatment protocols, however, there is still a gap of knowledge in high quality evidence for the most effective approach. Purpose : The aim of the study is to evaluate clinical long term implant stability and radiographic vertical bone height gain after implant placement in posterior maxilla using crestal sinus approach in comparison to lateral sinus elevation technique. Materials and Methods: Thirty patients have single maxillary posterior tooth in atrophic maxilla will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will receive implants using crestal sinus approach and group 2 (control group) will be assigned to the lateral sinus elevation technique, no bone grafts will be placed in both groups. Resonance frequency analysis will be employed to measure implant stability with a dedicated device (Osstell). For each implant, implant stability quotient ISQ values will be measured from the four sites.The mean of all measurements will be rounded to a whole number and regarded as the final ISQ of the implant. ISQ values will be obtained after implant insertion, at 3 months after delivery of the final restoration, at 6 and 12 months post-surgical. CBCT will be taken at 3 &12 months follow up periods, to assess the amount of bone height gained around the dental implants in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Clinical examination and preoperative evaluation using CBCT:

    1. 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.
    2. A preoperative CBCT will be 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.
  2. Random allocation: The patients will be divided into two groups with random allocation. Allocation ratio is 1:1. Randomization list will be provided using computerized excel sheet and will be concealed to the principle investigator till the time of the surgery, and will be kept with a contributor (Ingy Kastour) a clinician in IDCE who is not involved in the trial procedures. A phone call will be done after administration of anesthesia to reveal the randomization sequence for each case.
  3. Blinding: The outcome assessors will be blinded, the outcome assessor (CoI-II) for the implant stability and the outcome assessor (CoI-V) for the vertical bone height difference obtained from blinded CBCTs, outcome assessor (CoI-III) of the other variables will be also blinded. Blinding of the principle investigator and participants cannot be achieved due to different surgical procedures

  4. Surgical procedure:

    After administration of local anesthesia, the allocation will be revealed, for the test group, a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm. For the control group, a full-thickness flap will be 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 will be 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 will be elevated across the sinus floor and up the medial wall and this elevation must extend anteriorly-posteriorly to provide the exposed sinus floor. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm(25). A resorbable collagen membrane will be placed over the window preparation in the lateral approach to prevent the flap tissue in cooperating inside the antrostomy and the osseointegration process. Primary closure of the flap will be achieved.

  5. Postoperative Care:

    1. Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
    2. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days).
    3. Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from the second day for 60 seconds, 15 ml each time, two times a day for 14 days.

    4. Patient self-care instructions:

      • Application of an ice bag 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 call the co-investigator and 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 three, six and twelve months.

After 3 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • International Dental Continuing Education (IDCE) centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1 Patients who have at least one missing posterior maxillary tooth. 2. Adults above the age of 18. 3. Bone height from 4mm to 6mm under the maxillary sinus assessed in CBCT. 4. Good oral hygiene. 5. Patient accepts to sign an informed consent.

Exclusion Criteria:

  1. Smokers.
  2. Pregnant and lactating females
  3. Medically compromised patients. as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III)
  4. Patients with active infection related at the site of implant/bone graft placement.
  5. Patients with untreated active periodontal diseases.
  6. Patients with parafunctional habits.
  7. Acute or chronic sinusitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: crestal sinus approach technique
Full thickness flap will be elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm
Procedure: crestal sinus approach technique
a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm.
Other Names:
  • zimmer biomed dental implants and crestal sinus approach
Active Comparator: lateral sinus elevation technique
a full-thickness flap will be 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 will be 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 will be elevated across the sinus floor and up the medial wall and this elevation must extend anteriorly-posteriorly to provide the exposed sinus floor. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take plac
Procedure: Lateral sinus approach
a full-thickness flap will be 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 will be 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 will be elevated across the sinus floor and up the medial wall and this elevation must extend anteriorly-posteriorly to provide the exposed sinus floor. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place
Other Names:
  • Zimmer biomed dental implants and lateral sinus approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term Implant stability
Time Frame: 3 - 6 - 12 months
Implant stability will be measured using Osstell to assess any changes in the implant stability over time and changes from baseline
3 - 6 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical bone height gain
Time Frame: 3 - 12 months
Measured by CBCT
3 - 12 months
Post-surgical pain
Time Frame: for 10 days after the surgery
Measured using Visual Analogue Scale (VAS) The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right).
for 10 days after the surgery
Patient satisfaction regarding the function
Time Frame: 12 months
Measured using Visual Analogue Scale (VAS) The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant.
12 months
Plaque Index
Time Frame: 3 - 6 - 12 months
Periodontal probe
3 - 6 - 12 months
Modified Bleeding Index
Time Frame: 3 - 6 - 12 months
Periodontal probe
3 - 6 - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Investigators

  • Principal Investigator: Ahmed I Abo El Futtouh, Master, Clinical Director of Implant Program - Misr International University
  • Study Director: Mariam S Hanna, Bsc, Dentist/Researcher - IDCE
  • Study Chair: Nael A Mina, Bsc, Misr International University
  • Study Chair: Abdel Rahman A Abdel Rahman, Master, IDCE
  • Study Director: Inas M El-Zayat, Doctor, Assoc. Professor - Operative department, Misr International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 21, 2024

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PER8273004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data can be shared

IPD Sharing Time Frame

One year

IPD Sharing Access Criteria

Principal investigator

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Implant Placement

Clinical Trials on crestal sinus approach technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe