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

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ClinicalTrials.gov Identifier: NCT03633968

Recruitment Status : Unknown

Verified August 2018 by ahmed mohammed khalil aldahouk, Cairo University.
Recruitment status was: Recruiting

First Posted : August 16, 2018

Last Update Posted : August 20, 2018

Sponsor:

Information provided by (Responsible Party):

ahmed mohammed khalil aldahouk, Cairo University

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

Condition or disease	Intervention/treatment	Phase
Atrophy of Edentulous Maxillary Alveolar Ridge	Procedure: maxillary sinus lift	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention 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:	Single (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
Primary Purpose:	Health Services Research
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
Actual Study Start Date :	July 1, 2018
Estimated Primary Completion Date :	May 2019
Estimated Study Completion Date :	June 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: maxillary sinus lift small antrostomy 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	Procedure: maxillary sinus lift maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement Other Name: implant placement
Active Comparator: maxillary sinus lift large antrostomy 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	Procedure: maxillary sinus lift maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement Other Name: implant placement

Outcome Measures

Primary Outcome Measures :

amount of bone formation [ Time Frame: after 6 months ]
measurement of amount of bone gained by using CBCT

Secondary Outcome Measures :

implant stability [ Time Frame: after 6 months ]
measurement of implant stability by using osstell

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633968

Contacts

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Contact: Ahmed a dahouk, BSD	00201011862613 ext 00201289847733	a7madmo97@gmail.com
Contact: Ahmed a dr khleel, BSD	0223642705	ethics@dentistry.cu.edu.eg

Locations

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Egypt
Faculty of Dentistry, Cairo University	Recruiting
Cairo, Al-Manial, Egypt, 11553
Contact: Ahmed a dahouk, BSD 01289847733 ethics@dentistry.cu.edu.eg
Contact: Ahmed Y dr khaleel 01069617691 ahmed.zayed@dentistry.cu.edu.eg

Sponsors and Collaborators

ahmed mohammed khalil aldahouk

Investigators

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Principal Investigator:	ahmed a dahouk, bsd	Cairo University

More Information

Publications:

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. Review.

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.

Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90.

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. Review.

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.

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.

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.

Hatziotis JC, Papanayotou PH, Trigonidis G. Benign mesenchymoma of the tongue: report of case. J Oral Surg. 1972 Jan;30(1):45-6.

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.

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Responsible Party:	ahmed mohammed khalil aldahouk, Principal Investigator(doctor), Cairo University
ClinicalTrials.gov Identifier:	NCT03633968
Other Study ID Numbers:	maxillary sinus augmentation
First Posted:	August 16, 2018 Key Record Dates
Last Update Posted:	August 20, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	web sites and journals

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by ahmed mohammed khalil aldahouk, Cairo University:


sinus augmentation,lifting

Additional relevant MeSH terms:

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Atrophy Pathological Conditions, Anatomical

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