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

NCT04309682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-08-26

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Misr International University

    lead OTHER

Principal Investigators

  • Ahmed I Abo El Futtouh, Master · Clinical Director of Implant Program - Misr International University

  • Inas M El-Zayat, Doctor · Assoc. Professor - Operative department, Misr International University

  • Mariam S Hanna, Bsc · Dentist/Researcher - IDCE

  • Nael A Mina, Bsc · Misr International University

  • Abdel Rahman A Abdel Rahman, Master · International Dental Contiuing Education

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-07-01
Completion
2024-08-21

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309682 on ClinicalTrials.gov