Simultaneous Implant Placement With Autogenous Bone Ring

NCT ID: NCT05403112

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-09-01

Brief Summary

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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

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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

Conditions

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Bone Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomization clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

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Group I: autogenous bone rings

sinus lifting was augmented by bone rings were harvested from chin

Group Type ACTIVE_COMPARATOR

Bone ring with open sinus lifting

Intervention Type 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.

GroupII : autogenous sticky bone

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

Group Type ACTIVE_COMPARATOR

Bone ring with open sinus lifting

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Sticky bone with open sinus lifting simultaneous implant

Eligibility Criteria

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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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Omar Saleh Ahmed Bassed

OTHER

Sponsor Role lead

Responsible Party

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Omar Saleh Ahmed Bassed

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cairo University

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Omar Bassed, Master

Role: CONTACT

+201093667522

Khaled El Hayes, Phd

Role: CONTACT

+20 100 1457045

Facility Contacts

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Omar Bassed, Master

Role: primary

00201093667522

Mohammed Omara, Phd

Role: backup

+20 01286004984

References

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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.

Reference Type RESULT
PMID: 33959236 (View on PubMed)

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.

Reference Type RESULT
PMID: 26644216 (View on PubMed)

Related Links

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Other Identifiers

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Simultaneous implant placement

Identifier Type: -

Identifier Source: org_study_id

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