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Simultaneous Implant Placement With Autogenous Bone Ring

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05403112
Acronym
RCT
Enrollment
26
Registered
2022-06-03
Start date
2022-09-01
Completion date
2023-09-01
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Graft

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.

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

Interventions

PROCEDUREBone 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.

Sponsors

Omar Saleh Ahmed Bassed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

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.

Intervention model description

randomization clinical trial

Eligibility

Sex/Gender
ALL
Age
26 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change bone gainImmediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measuredbone gain (increase bone volume) Measuring the crestal bone height by CT.

Countries

Egypt

Contacts

Primary ContactOmar Bassed, Master
Omarsaleh@dentistry.cu.edu.eg+201093667522
Backup ContactKhaled El Hayes, Phd
Kahed.atef@denistry.cu.edu.eg+20 100 1457045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026