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Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement

Primary Purpose

Atrophy of Edentulous Maxillary Alveolar Ridge

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
maxillary sinus lift
Sponsored by
ahmed mohammed khalil aldahouk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrophy of Edentulous Maxillary Alveolar Ridge focused on measuring sinus augmentation,lifting

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm.
  2. Both sexes
  3. No intraoral soft and hard tissue pathology,
  4. No systemic condition that contraindicate implant placement

Exclusion Criteria:

  1. Sinus pathology.
  2. Heavy smokers more than 20 cigarettes per day.
  3. Patients with systemic disease that may affect normal healing.
  4. Psychiatric problems.
  5. Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site

Sites / Locations

  • Faculty of Dentistry, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

maxillary sinus lift small antrostomy

maxillary sinus lift large antrostomy

Arm Description

local anaesthesia will be given flap will be reflected to expose sinus lateral wall. round diamond bur will be used to make small antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement

local anaesthesia will be given flap will be reflected to expose sinus lateral wall round diamond bur will be used to make large antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement

Outcomes

Primary Outcome Measures

amount of bone formation
measurement of amount of bone gained by using CBCT

Secondary Outcome Measures

implant stability
measurement of implant stability by using osstell

Full Information

First Posted
August 13, 2018
Last Updated
August 16, 2018
Sponsor
ahmed mohammed khalil aldahouk
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1. Study Identification

Unique Protocol Identification Number
NCT03633968
Brief Title
Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement
Official Title
Assessment of the Effect of the Antrostomy Size in Graftless Lateral Maxillary Sinus Floor Elevation Using AMBE (Antral Membrane Balloon Elevation) With Simultaneous Implant Placement
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ahmed mohammed khalil aldahouk

4. Oversight

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

5. Study Description

Brief Summary
two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement
Detailed Description
control group undergoes for graftless sinus lift using AMBE through large antrostomy with simultaneous implant placement. While, study group undergo for graftless sinus lift using AMBE through small antrostomy with simultaneous implant placement. the aim of the study is assessment the effect of antrostomy size on bone formation in graftless sinus lift with simultaneous implant placement. CBCT will be done before and after the surgery and after 6 months to assess of amount bone gain in mm. implant stability after 6 months will be determined by using Osstell. Primary outcome: amount of bone gain which will be measured by using linear measurement from CBCT. secondary outcome: stability of implant by using osstell

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Maxillary Alveolar Ridge
Keywords
sinus augmentation,lifting

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement
Masking
Participant
Masking Description
assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
maxillary sinus lift small antrostomy
Arm Type
Active Comparator
Arm Description
local anaesthesia will be given flap will be reflected to expose sinus lateral wall. round diamond bur will be used to make small antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement
Arm Title
maxillary sinus lift large antrostomy
Arm Type
Active Comparator
Arm Description
local anaesthesia will be given flap will be reflected to expose sinus lateral wall round diamond bur will be used to make large antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement
Intervention Type
Procedure
Intervention Name(s)
maxillary sinus lift
Other Intervention Name(s)
implant placement
Intervention Description
maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement
Primary Outcome Measure Information:
Title
amount of bone formation
Description
measurement of amount of bone gained by using CBCT
Time Frame
after 6 months
Secondary Outcome Measure Information:
Title
implant stability
Description
measurement of implant stability by using osstell
Time Frame
after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm. Both sexes No intraoral soft and hard tissue pathology, No systemic condition that contraindicate implant placement Exclusion Criteria: Sinus pathology. Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Psychiatric problems. Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed a dahouk, BSD
Phone
00201011862613
Ext
00201289847733
Email
a7madmo97@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed a dr khleel, BSD
Phone
0223642705
Email
ethics@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed a dahouk, bsd
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
Al-Manial
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed a dahouk, BSD
Phone
01289847733
Email
ethics@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed Y dr khaleel
Phone
01069617691
Email
ahmed.zayed@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
web sites and journals
Citations:
PubMed Identifier
22117952
Citation
Stern A, Green J. Sinus lift procedures: an overview of current techniques. Dent Clin North Am. 2012 Jan;56(1):219-33, x. doi: 10.1016/j.cden.2011.09.003.
Results Reference
background
PubMed Identifier
7994726
Citation
Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
Results Reference
background
PubMed Identifier
15871527
Citation
Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90. doi: 10.1563/0-773.1.
Results Reference
background
PubMed Identifier
20467595
Citation
Esposito M, Grusovin MG, Rees J, Karasoulos D, Felice P, Alissa R, Worthington H, Coulthard P. Effectiveness of sinus lift procedures for dental implant rehabilitation: a Cochrane systematic review. Eur J Oral Implantol. 2010 Spring;3(1):7-26.
Results Reference
background
PubMed Identifier
25872947
Citation
Watanabe T, Nakagawa E, Saito K, Ohshima H. Differences in Healing Patterns of the Bone-Implant Interface between Immediately and Delayed-Placed Titanium Implants in Mouse Maxillae. Clin Implant Dent Relat Res. 2016 Feb;18(1):146-60. doi: 10.1111/cid.12280. Epub 2015 Apr 15. Erratum In: Clin Implant Dent Relat Res. 2020 Oct;22(5):655.
Results Reference
background
PubMed Identifier
23057039
Citation
Avila-Ortiz G, Wang HL, Galindo-Moreno P, Misch CE, Rudek I, Neiva R. Influence of lateral window dimensions on vital bone formation following maxillary sinus augmentation. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1230-8.
Results Reference
background
PubMed Identifier
23057031
Citation
Testori T, Weinstein RL, Taschieri S, Del Fabbro M. Risk factor analysis following maxillary sinus augmentation: a retrospective multicenter study. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1170-6.
Results Reference
background
PubMed Identifier
4500328
Citation
Hatziotis JC, Papanayotou PH, Trigonidis G. Benign mesenchymoma of the tongue: report of case. J Oral Surg. 1972 Jan;30(1):45-6. No abstract available.
Results Reference
background
PubMed Identifier
18371101
Citation
Barone A, Santini S, Marconcini S, Giacomelli L, Gherlone E, Covani U. Osteotomy and membrane elevation during the maxillary sinus augmentation procedure. A comparative study: piezoelectric device vs. conventional rotative instruments. Clin Oral Implants Res. 2008 May;19(5):511-5. doi: 10.1111/j.1600-0501.2007.01498.x. Epub 2008 Mar 26.
Results Reference
background

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Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement

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