search
Back to results

Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

Primary Purpose

Maxillary Sinus Floor Augmentation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Osseodensification Internal Sinus Lift
Osteotome Internal Sinus Lift
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Sinus Floor Augmentation focused on measuring Osseodensification, Osteotome, Internal Sinus Lifting, Sticky Bone

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.

    2. Both sexes will be selected males and females.

    3. Adult patients aged between 18 and 40 years of age.

    4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).

    5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.

    6. No previous surgery or radiation treatment on the maxillary sinus.

Exclusion Criteria:

  • 1. Smokers.

    2. Pregnant or lactating females.

    3. Psychiatric disorders.

    4. Uncontrolled systemic disease.

    5. Hematologic diseases and coagulation disorders.

    6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.

    7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.

    8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Sites / Locations

  • Faculty of Dentistry- Assiut UniversityRecruiting
  • Faculty of Dentistry- Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osseodensification Internal Sinus Lift / Sticky Bone graft material

Osteotome Internal Sinus Lift /Sticky Bone graft material

Arm Description

Osseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.

Osteotome Internal Sinus Lift will be performed using sticky bone as a graft material.

Outcomes

Primary Outcome Measures

Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).
The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.
Radiographic Assessment of Change in the Bone Density.
The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.

Secondary Outcome Measures

Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.
The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters. ( low torque (<30), medium torque (30 < Insertion Torque < 50), and high torque (>50).
Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.
The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .
Patient's Post-Operative Pain Assessment
The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)
Patient's Satisfaction Assessment.
The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.
Operator's Satisfaction Assessment
The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.

Full Information

First Posted
August 5, 2022
Last Updated
November 14, 2022
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05495490
Brief Title
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement
Official Title
Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The sinus lift technique through alveolar crest Osseodensification is conservative, minimally invasive, and minimally traumatic, utilizing hydropneumatic counterclockwise rotating instruments to lift the maxillary sinus floor without touching the Schneiderian membrane, thereby minimizing the risk of perforation. In contrast, the internal sinus lift technique utilizing osteotomes to raise the Schneiderian membrane eliminated hammering, making the technique more patient-friendly, with the placement of a graft biomaterial around the implant. The challenge in this technique was the availability of > 5mm residual bone height preventing membrane perforation and low primary implant stability. Consequently, the investigator aims to compare the efficacy and clinical outcomes of Osseodensification and Osteotome internal sinus lifting after delayed implant placement by assessing bone gain and bone density around implants radiographically, the primary stability of the implants clinically, and patient satisfaction.
Detailed Description
Twenty patients with maxillary posterior edentulous ridge will be randomly assigned to one of two equal groups: Osseodensification sinus lift using sticky bone as a graft material (Group 1) and Osteotome internal sinus lift using sticky bone as a graft material (Group 2). (Group 2). Using Cone Beam Computed Tomography (CBCT), the sinus anatomy and height and width of the residual ridge from the sinus floor to the alveolar crest of all patients will be evaluated prior to surgery. Each patient will then receive pre-surgical medication consisting of intravenous steroidal anti-inflammatory drug (dexamethasone sodium phosphate 4mg) one hour prior to the procedure and oral rinsing with 0.12 percent chlorhexidine for one minute. After surgery, patients will receive 14 days of twice-daily chlorhexidine rinses 0.12 percent for postoperative treatment. Patients allergic to penicillin are given 1 g amoxicillin twice daily for six days or 0.5 g azithromycin. Ibuprofen (400) should be administered three times daily unless medically contraindicated. After insertion, the primary stability of each implant will be evaluated using a torque wrench and an Osstell device. All patients will undergo immediate postoperative CBCTs to assess bone gain and bone density. Utilizing the Visual Analogue Scale, patients' pain will be evaluated (VAS). A health-related quality of life questionnaire will be used to evaluate the patients' perception of recovery in terms of pain, oral function, general activity, and other symptoms. Postoperatively, the operator's subjective satisfaction with Osseodensification and Osteotome sinus lift techniques will be evaluated using a second printed questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Sinus Floor Augmentation
Keywords
Osseodensification, Osteotome, Internal Sinus Lifting, Sticky Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel single-blind masking randomized controlled clinical trial
Masking
Participant
Masking Description
Computer-generated randomization table
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osseodensification Internal Sinus Lift / Sticky Bone graft material
Arm Type
Experimental
Arm Description
Osseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.
Arm Title
Osteotome Internal Sinus Lift /Sticky Bone graft material
Arm Type
Active Comparator
Arm Description
Osteotome Internal Sinus Lift will be performed using sticky bone as a graft material.
Intervention Type
Procedure
Intervention Name(s)
Osseodensification Internal Sinus Lift
Intervention Description
The osteotomy for the Osseodensification internal sinus lift begins with the advancement of a twist drill at 800 rpm and saline irrigation to within 1-2 mm of the sinus floor. The osteotomy is then widened by employing a series of osteotomy drills rotating at 800 rpm. Infracture of the sinus has occurred when the final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation ("haptic feedback") occurs. After infracture, the graft material will be injected into the osteotomy site. Using the final osteotomy drill, the graft is guided apically. This procedure is repeated incrementally to raise the membrane. Once sufficient space has been created beneath the antral membrane, the implant will be inserted followed by suturing.
Intervention Type
Procedure
Intervention Name(s)
Osteotome Internal Sinus Lift
Other Intervention Name(s)
Bone-Added Osteotome Sinus Floor Elevation Technique, Summers Osteotome Technique
Intervention Description
The osteotomy for the Osteotome internal sinus lift will begin with standard drills and saline irrigation to prepare the implant socket with a working length that is 1-2 mm shorter than the residual bone height as determined by radiographic examination. After preparation, a series of osteotomes of varying diameters will be sequentially utilized to widen the osteotomy and elevate the Schneiderian membrane by vertical tapping to create a "greenstick" fracture. The Valsalva maneuver (nasal blowing test) will be performed to determine the integrity of the Schneiderian membrane. During the osteotomy, the graft material will be injected and slowly placed into the elevated space using osteotomes until the desired depth is reached. Implant placement and suturing will conclude the procedure.
Primary Outcome Measure Information:
Title
Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).
Description
The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.
Time Frame
Pre-operative and Immediately post-operative.
Title
Radiographic Assessment of Change in the Bone Density.
Description
The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.
Time Frame
Pre-operative and Immediately post-operative.
Secondary Outcome Measure Information:
Title
Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.
Description
The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters. ( low torque (<30), medium torque (30 < Insertion Torque < 50), and high torque (>50).
Time Frame
During procedure.
Title
Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.
Description
The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .
Time Frame
During procedure.
Title
Patient's Post-Operative Pain Assessment
Description
The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)
Time Frame
1 week post-operative
Title
Patient's Satisfaction Assessment.
Description
The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.
Time Frame
1 week post-operative
Title
Operator's Satisfaction Assessment
Description
The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months. 2. Both sexes will be selected males and females. 3. Adult patients aged between 18 and 40 years of age. 4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ). 5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT. 6. No previous surgery or radiation treatment on the maxillary sinus. Exclusion Criteria: 1. Smokers. 2. Pregnant or lactating females. 3. Psychiatric disorders. 4. Uncontrolled systemic disease. 5. Hematologic diseases and coagulation disorders. 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status. 7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids. 8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omneya M. Elkadi, Ass.Lecturer
Phone
00201121844448
Email
ninielkadi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala A. Abuel- Ela, Professor
Organizational Affiliation
Faculty of Dentistry- Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed W. Bissar, Lecturer
Organizational Affiliation
Faculty of Dentistry- Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omneya M. Elkadi
Organizational Affiliation
Faculty of Dentistry- Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry- Assiut University
City
Assiut
ZIP/Postal Code
71517
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omneya M. Elkadi, Ass.Lecturer
Phone
00201121844448
Email
ninielkadi@gmail.com
Facility Name
Faculty of Dentistry- Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omneya M. Elkadi, Ass.Lecturer
Phone
00201121844448
Email
ninielkadi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article after deidentification. (Text, tables, figures and appendices).
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary identified for this purpose")
Citations:
PubMed Identifier
30427961
Citation
Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
Results Reference
background
PubMed Identifier
25123761
Citation
Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
Results Reference
background
PubMed Identifier
27235382
Citation
Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.
Results Reference
background
PubMed Identifier
26814997
Citation
Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
Results Reference
background
PubMed Identifier
35208017
Citation
Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenco ES, Leite PEC, Mourao CFAB, Sohn DS, Calasans-Maia MD. "Sticky Bone" Preparation Device: A Pilot Study on the Release of Cytokines and Growth Factors. Materials (Basel). 2022 Feb 16;15(4):1474. doi: 10.3390/ma15041474.
Results Reference
background
PubMed Identifier
29181458
Citation
Zhou X, Hu XL, Li JH, Lin Y. Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. Chin J Dent Res. 2017;20(4):211-218. doi: 10.3290/j.cjdr.a39220.
Results Reference
background
PubMed Identifier
17695343
Citation
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Results Reference
background

Learn more about this trial

Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

We'll reach out to this number within 24 hrs