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

NCT04309682 | Completed

• 1 other identifier: PER8273004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant Placement

Keywords

Crestal sinus approach; lateral sinus approach; implant stability

Outcome Measures

Primary Outcomes (1)

• Long term Implant stability

  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 Outcomes (5)

• Vertical bone height gain

  3 - 12 months

• Post-surgical pain

  for 10 days after the surgery

• Patient satisfaction regarding the function

  12 months

• Plaque Index

  3 - 6 - 12 months

• Modified Bleeding Index

  3 - 6 - 12 months

Study Arms (2)

crestal sinus approach technique

EXPERIMENTAL

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

lateral sinus elevation technique

ACTIVE COMPARATOR

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

Interventions

crestal sinus approach technique PROCEDURE

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.

Also known as: zimmer biomed dental implants and crestal sinus approach

crestal sinus approach technique

Lateral sinus approach PROCEDURE

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

Also known as: Zimmer biomed dental implants and lateral sinus approach

lateral sinus elevation technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Smokers.
• Pregnant and lactating females
• 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)
• 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.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

International Dental Continuing Education (IDCE) centre

Cairo, Egypt

Location

Related Publications (30)

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  BACKGROUND

Study Officials

• Ahmed I Abo El Futtouh, Master

  Clinical Director of Implant Program - Misr International University

  PRINCIPAL INVESTIGATOR

• Inas M El-Zayat, Doctor

  Assoc. Professor - Operative department, Misr International University

  STUDY DIRECTOR

• Mariam S Hanna, Bsc

  Dentist/Researcher - IDCE

  STUDY DIRECTOR

• Nael A Mina, Bsc

  Misr International University

  STUDY CHAIR

• Abdel Rahman A Abdel Rahman, Master

  International Dental Contiuing Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director of Implant Program - Periodontology and Implantology Consultant

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: December 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: August 21, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: One year
• Access Criteria: Principal investigator

Locations

EG (1)