NCT05565261

Brief Summary

Objectives: The purpose of this study is to evaluate bite force (BF), oral health-related quality of life (OHRQoL), and patient satisfaction in 2-implant-supported overdentures. In addition, the effects of clinical parameters such as age, gender, implant length, implant diameter, locator attachment height, attachment color, and interimplant distance were also evaluated. Material and Methods: A total of 51 patients were included in the study. BFs were measured with a force meter in complete dentures and implant-supported overdentures. OHRQoL was assessed with the Oral Health Impact Profile (OHIP-14) and patient satisfaction was assessed with the Visual Analog Scale (VAS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

June 23, 2022

Last Update Submit

September 6, 2023

Conditions

Edentulous JawPatient Satisfaction

Keywords

bite forcecomplete dentureimplant supported overdenturespatient satisfactionquality of life

Outcome Measures

Primary Outcomes (7)

  • Bite force

    Bite force in Newton

    December 2019-January 2022

  • Interimplant distance

    Interimplant distance in millimeters

    December 2019-January 2022

  • The height of the locator attachment

    The height of the locator attachment is in millimeters.

    December 2019-January 2022

  • Quality of Life

    Quality of Life was assessed using the Oral Health Impact Profile(OHIP-14) (0-4 units, 0 for never to 4 for always).

    December 2019-January 2022

  • Patient satisfaction

    Patient satisfaction was assessed using the VAS(visual analogue scale, 1-5 units, 1 not satisfied to totally satisfied).

    December 2019-January 2022

  • Dental implant length

    Dental implant length in millimeters

    December 2019-January 2022

  • Dental implant diameter

    Dental implant diameter in millimeters

    December 2019-January 2022

Study Arms (2)

Group 1: Complete Dentures

The group consists of patients using conventional complete dentures applied to edentulous patients.

Device: complete denture

Group 2: Implant Supported Overdentures

The group consists of patients who use implant-supported overdentures after 2 dental implants have been surgically placed in edentulous patients and osseointegration has occurred.

Device: complete denture

Interventions

complete dentureDEVICE

Bite force was measured with a bite force measuring device. Quality of life and patient satisfaction were evaluated with questionnaires.

Group 1: Complete DenturesGroup 2: Implant Supported Overdentures

Eligibility Criteria

Age47 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who were completely edentulous were included in the study.

You may qualify if:

  • Patients without pathology in intraoral tissues
  • Patients who have not experienced implant loss until the prosthesis stage
  • Patients without any systemic disease that would endanger the prognosis of the implant
  • Patients with good bilateral balanced occlusion
  • Patients who could understand and answer the questions in the questionnaire were included in the study.

You may not qualify if:

  • Patients with parafunctional habits
  • Patients with masticatory muscles or temporomandibular joint complaints
  • Patients using drugs that affect muscle activity
  • Patients who did not come to the control session on time were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Nur Avukat

Odunpazari, Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (6)

  • Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Heydecke G, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais JA, 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. Gerodontology. 2002 Jul;19(1):3-4. No abstract available.

    PMID: 12164236RESULT

  • Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.

    PMID: 19696851RESULT

  • Mumcu E, Bilhan H, Geckili O. The effect of attachment type and implant number on satisfaction and quality of life of mandibular implant-retained overdenture wearers. Gerodontology. 2012 Jun;29(2):e618-23. doi: 10.1111/j.1741-2358.2011.00531.x. Epub 2011 Jul 4.

    PMID: 21726276RESULT

  • Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.

    PMID: 24158342RESULT

  • Wang Y, Baumer D, Ozga AK, Korner G, Baumer A. Patient satisfaction and oral health-related quality of life 10 years after implant placement. BMC Oral Health. 2021 Jan 14;21(1):30. doi: 10.1186/s12903-020-01381-3.

    PMID: 33446161RESULT

  • Enkling N, Saftig M, Worni A, Mericske-Stern R, Schimmel M. Chewing efficiency, bite force and oral health-related quality of life with narrow diameter implants - a prospective clinical study: results after one year. Clin Oral Implants Res. 2017 Apr;28(4):476-482. doi: 10.1111/clr.12822. Epub 2016 Mar 24.

    PMID: 27009835RESULT

MeSH Terms

Conditions

Jaw, EdentulousPatient Satisfaction

Interventions

Denture, Complete

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Esra Avukat

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2022

First Posted

October 4, 2022

Study Start

December 17, 2019

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)