Clinical trial NCT03633968: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
Keywords: sinus augmentation,lifting
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: amount of bone formation
timeFrame: after 6 months
Secondary outcomes:
measure: implant stability
timeFrame: after 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Al-Manial
Study officials:
affiliation: Cairo University
name: ahmed a dahouk, bsd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90. doi: 10.1563/0-773.1.
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.
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.
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.
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.
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.
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.