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

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

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

Study Overview

• Status: Unknown
• Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
• Intervention / Treatment: Procedure: maxillary sinus lift

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 Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of bone formation	measurement of amount of bone gained by using CBCT	after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant stability	measurement of implant stability by using osstell	after 6 months

Collaborators and Investigators

• Sponsor: ahmed mohammed khalil aldahouk
• Investigators: Principal Investigator: ahmed a dahouk, bsd, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol. 2005;31(2):85-90. doi: 10.1563/0-773.1.
• 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.
• 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. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: sinus augmentation,lifting
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: maxillary sinus augmentation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: web sites and journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No