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

NCT03633968 | Unknown

• 1 other identifier: maxillary sinus augmentation
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement

Conditions

Atrophy of Edentulous Maxillary Alveolar Ridge

Keywords

sinus augmentation,lifting

Outcome Measures

Primary Outcomes (1)

• amount of bone formation

  measurement of amount of bone gained by using CBCT

  after 6 months

Secondary Outcomes (1)

• implant stability

  after 6 months

Study Arms (2)

maxillary sinus lift small antrostomy

ACTIVE COMPARATOR

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 lift large antrostomy

ACTIVE COMPARATOR

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

Interventions

maxillary sinus lift PROCEDURE

maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement

Also known as: implant placement

maxillary sinus lift large antrostomy; maxillary sinus lift small antrostomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ahmed mohammed khalil aldahouk: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Al-Manial, 11553, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 22117952 BACKGROUND

• 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.

  PMID: 7994726 BACKGROUND

• Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90. doi: 10.1563/0-773.1.

  PMID: 15871527 BACKGROUND

• 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.

  PMID: 20467595 BACKGROUND

• 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.

  PMID: 25872947 BACKGROUND

• 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.

  PMID: 23057039 BACKGROUND

• 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.

  PMID: 23057031 BACKGROUND

• 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.

  PMID: 4500328 BACKGROUND

• 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.

  PMID: 18371101 BACKGROUND

Study Officials

• ahmed a dahouk, bsd

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed a dahouk, BSD

CONTACT

00201011862613; a7madmo97@gmail.com

Ahmed a dr khleel, BSD

CONTACT

0223642705; ethics@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator(doctor)

Model Details: 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 Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: July 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

EG (1)