Simultaneous Implant Placement With Autogenous Bone Ring (RCT)

Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting " Randomization Clinical Trial"

This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Graft
• Intervention / Treatment: Procedure: Bone ring with open sinus lifting

Detailed Description

The main prerequisite of achieving proper implant placement with ideal functional and proper restoration particularly in the posterior maxilla may compromise with violation to Schneiderian membrane especially in pneumatized maxillary Antrum when RBH < 4 mm, Conventional lateral sinus floor elevation (CLSFE) is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics in severe atrophic maxilla.

The objective of this study was to evaluate sinus elevation with simultaneous implant placement using open technique and bone ring versus sticky bone clinically and radiographically in terms of secondary stability and bone gain around the implant

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar Bassed, Master; Phone Number: +201093667522; Email: Omarsaleh@dentistry.cu.edu.eg
• Study Contact Backup: Name: Khaled El Hayes, Phd; Phone Number: +20 100 1457045; Email: Kahed.atef@denistry.cu.edu.eg

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Cairo University
      • Contact: Omar Bassed, Master; Phone Number: 00201093667522; Email: Omarsaleh@dentistry.cu.edu.eg
      • Contact: Mohammed Omara, Phd; Phone Number: +20 01286004984; Email: omara_mohammed@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with edentulous vertically deficient posterior maxillary ridge a 4-5 mm. height of alveolar bone.
• Both males as well as females without any active periodontal disease.
• All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
• All selected patients are non-smokers and non-alcoholics.
• Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
• The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

• On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
• General contraindications to implant surgery.
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
• Active infection or severe inflammation in the area intended for implant placement.
• Need of bone augmentation procedures at implant placement.
• Unable to open mouth sufficiently to accommodate the surgical tooling.
• Patients participating in other studies, if the present protocol could not be properly followed.
• Referred only for implant placement or unable to attend a 5-year follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I: autogenous bone rings; sinus lifting was augmented by bone rings were harvested from chin	Procedure: Bone ring with open sinus lifting; All patients involved in this study will be divided in to two group each group will receive a different technique of sinus lifting use autogenous bone ring technique with study group and autogenous sticky bone with control group.; Other Names: Sticky bone with open sinus lifting; simultaneous implant
ACTIVE_COMPARATOR: GroupII : autogenous sticky bone; sinus lifting was augmented by autogenous sticky bone was harvested from chin and immediate implant placement	Procedure: Bone ring with open sinus lifting; All patients involved in this study will be divided in to two group each group will receive a different technique of sinus lifting use autogenous bone ring technique with study group and autogenous sticky bone with control group.; Other Names: Sticky bone with open sinus lifting; simultaneous implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change bone gain	bone gain (increase bone volume) Measuring the crestal bone height by CT.	Immediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measured

Collaborators and Investigators

• Sponsor: Omar Saleh Ahmed Bassed

Publications and helpful links

General Publications

• Starch-Jensen T, Deluiz D, Vitenson J, Bruun NH, Tinoco EMB. Maxillary Sinus Floor Augmentation with Autogenous Bone Graft Compared with a Composite Grafting Material or Bone Substitute Alone: a Systematic Review and Meta-Analysis Assessing Volumetric Stability of the Grafting Material. J Oral Maxillofac Res. 2021 Mar 31;12(1):e1. doi: 10.5037/jomr.2021.12101. eCollection 2021 Jan-Mar.
• Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.

Helpful Links

• Egyptian dental journal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: May 29, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (ACTUAL): June 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Simultaneous implant placement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No