Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment

NCT04438616 | Unknown

• 1 other identifier: 3042020
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design.which the inclusion criteria is completely edentulous patient ,Age range from 40 to 70 year old ,skeletal class 1, both sexes
• Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
• Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (2)

• name of measurement: Patient satisfaction

  Denture satisfaction questionnaire

  Patient satisfaction measure in 2 weak

• name of measurement: Patient satisfaction

  Denture satisfaction questionnaire

  Patient satisfaction measure in 12 weak

Secondary Outcomes (5)

• name of measurement: implant stability

  Implant stability will be measure at day of implant

• name of measurement: implant stability

  Implant stability will be measure after 2 weak

• name of measurement: implant stability

  Implant stability will be measure after 4 weak

• name of measurement: implant stability

  Implant stability will be measure after 8 weak

• name of measurement: implant stability

  Implant stability will be measure after 12 weak

Study Arms (2)

dome magnetic attachment

ACTIVE COMPARATOR

* A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. * Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor * We connect magnetic attachment(dome) for each groups on complete denture by pick up procedure at day of implant installation

Procedure: dome magnetic attachment

flat magnetic attachment

ACTIVE COMPARATOR

* A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed. * Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor * We connect magnetic attachment(flat) for each groups on complete denture by pick up procedure at day of implant installation

Procedure: flat magnetic attachment

Interventions

dome magnetic attachment PROCEDURE

* All patients will receive complete denture before implant installation . * The CBCT examination should be take * patients received infiltration local anesthesia * A crestal incision is made using No. 15 c blade . * Full sequential drilling under copious saline irrigation will be made . insertion of two implant by the contra angle handpiece with special adaptor * We connect magnetic attachment(dome) on complete denture by pick up procedure at day of implant installation. * Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. * Patient satisfaction measure

dome magnetic attachment

flat magnetic attachment PROCEDURE

* All patients will receive complete denture before implant installation . * The CBCT examination should be take * patients received infiltration local anesthesia. * A crestal incision is made using No. 15 c blade * Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant by the contra angle handpiece with special adaptor * We connect magnetic attachment(flat) on complete denture by pick up procedure at day of implant installation. * Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks. * Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

flat magnetic attachment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• completely edentulous patient.
• Age range from 40 to 70 year old
• Skeletal class 1
• Both sexes.

You may not qualify if:

• No intra oral soft and hard tissue pathology
• Heavy smokers more than 20 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Patient with sever parafunctional occlusal activity.
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability,.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• Boerrigter EM, Geertman ME, Van Oort RP, Bouma J, Raghoebar GM, van Waas MA, van't Hof MA, Boering G, Kalk W. Patient satisfaction with implant-retained mandibular overdentures. A comparison with new complete dentures not retained by implants--a multicentre randomized clinical trial. Br J Oral Maxillofac Surg. 1995 Oct;33(5):282-8. doi: 10.1016/0266-4356(95)90038-1.

  PMID: 8555143 BACKGROUND

• Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. doi: 10.1067/mpr.2001.113214.

  PMID: 11208203 BACKGROUND

• Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.

  PMID: 12182304 BACKGROUND

• Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.

  PMID: 4500507 BACKGROUND

• Barao VA, Assuncao WG, Tabata LF, Delben JA, Gomes EA, de Sousa EA, Rocha EP. Finite element analysis to compare complete denture and implant-retained overdentures with different attachment systems. J Craniofac Surg. 2009 Jul;20(4):1066-71. doi: 10.1097/SCS.0b013e3181abb395.

  PMID: 19553853 BACKGROUND

Central Study Contacts

hussein H moalla, bachelor

CONTACT

02201021422480; husein_hatam@yahoo.com

runnd s zwain, bachelor

CONTACT

01101034909

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main-Supervisor :Dr.Ahmed fahmy (Ass.professor of prosthodontics, faculity of dentistry ,cairo university ) \co-supervisor :Amr ahmednaguib (lecturer of prosthodontic ) \ Principle Investigator.:Hussein hatam jawad

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: September 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share