Simultaneous Implant Placement With Autogenous Bone Ring

NCT05403112 | Unknown

• 1 other identifier: Simultaneous implant placement
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Graft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I: autogenous bone rings

ACTIVE COMPARATOR

sinus lifting was augmented by bone rings were harvested from chin

Procedure: Bone ring with open sinus lifting

GroupII : autogenous sticky bone

ACTIVE COMPARATOR

sinus lifting was augmented by autogenous sticky bone was harvested from chin and immediate implant placement

Procedure: Bone ring with open sinus lifting

Interventions

Bone ring with open sinus lifting PROCEDURE

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.

Also known as: Sticky bone with open sinus lifting, simultaneous implant

Group I: autogenous bone rings; GroupII : autogenous sticky bone

Eligibility Criteria

• Age: 26 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omar Saleh Ahmed Bassed: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (2)

• 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.

  PMID: 33959236 RESULT

• 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.

  PMID: 26644216 RESULT

Related Links

• Egyptian dental journal

Central Study Contacts

Omar Bassed, Master

CONTACT

+201093667522; Omarsaleh@dentistry.cu.edu.eg

Khaled El Hayes, Phd

CONTACT

+20 100 1457045; Kahed.atef@denistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: This trial is considered a randomized double blind clinical trial due to the following: 1. The participant will be blinded to the technique that will be used during the surgical operation. 2. The outcome assessor will be blinded 3. The operator (DR.O.S.) will not be blinded for both techniques during the surgical operation, as the two techniques are different. (Dr. M.O.). The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting

Model Details: randomization clinical trial

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 3, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)