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

Atrophy of Edentulous Maxillary Alveolar Ridge Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633968
• Other study ID #: maxillary sinus augmentation
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: Ahmed a dahouk, BSD
• Phone: 00201011862613
• Email: a7madmo97[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Edentulous Maxillary Alveolar Ridge

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	Al-Manial

Sponsors (1)

Lead Sponsor	Collaborator
ahmed mohammed khalil aldahouk

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View 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. — View 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. Review. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of bone formation	measurement of amount of bone gained by using CBCT	after 6 months
Secondary	implant stability	measurement of implant stability by using osstell	after 6 months