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

NCT ID: NCT03633968

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Atrophy of Edentulous Maxillary Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
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 Groups

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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

Group Type ACTIVE_COMPARATOR

maxillary sinus lift

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

maxillary sinus lift

Intervention Type PROCEDURE

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

Interventions

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maxillary sinus lift

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

Intervention Type PROCEDURE

Other Intervention Names

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implant placement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ahmed mohammed khalil aldahouk

OTHER

Sponsor Role lead

Responsible Party

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ahmed mohammed khalil aldahouk

Principal Investigator(doctor)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ahmed a dahouk, bsd

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Dentistry, Cairo University

Cairo, Al-Manial, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed a dahouk, BSD

Role: CONTACT

00201011862613 ext. 00201289847733

Ahmed a dr khleel, BSD

Role: CONTACT

0223642705

Facility Contacts

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Ahmed a dahouk, BSD

Role: primary

01289847733

Ahmed Y dr khaleel

Role: backup

01069617691

References

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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.

Reference Type BACKGROUND
PMID: 22117952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7994726 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15871527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20467595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25872947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23057039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23057031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4500328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18371101 (View on PubMed)

Other Identifiers

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maxillary sinus augmentation

Identifier Type: -

Identifier Source: org_study_id

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