RCT: Simultaneous Implant Placement With Autogenous Bone Ring

Sponsor

Omar Saleh Ahmed Bassed (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05403112

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Graft	Procedure: Bone ring with open sinus lifting	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomization clinical trialrandomization clinical trial

Masking:

Single (Care Provider)

Masking Description:

This trial is considered a randomized double blind clinical trial due to the following: The participant will be blinded to the technique that will be used during the surgical operation. The outcome assessor will be blinded 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Other Names:

Sticky bone with open sinus lifting

simultaneous implant

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

26 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo	Giza	Egypt	12613

Sponsors and Collaborators

Omar Saleh Ahmed Bassed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Egyptian dental journal

Publications

None provided.

Responsible Party:

Omar Saleh Ahmed Bassed, Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting, Cairo University

ClinicalTrials.gov Identifier:

NCT05403112

Other Study ID Numbers:

Simultaneous implant placement

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 27, 2022