Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses

8. März 2021 aktualisiert von: Iman Abd-ElWahab Radi, PhD

Assessment Of Patient Satisfaction and Oral-health Related Quality of Life In Completely Edentulous Patients Receiving Removable Implant Overdentures Versus Fixed Implant Overdentures: A Randomized Clinical Trial

Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients were randomized to receive either a fixed or a removable maxillary and mandibular full arch implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.

Studienübersicht

Detaillierte Beschreibung

Interventions

General operative procedures:

Once the eligibility criteria were fulfilled in a patient, new complete maxillary and mandibular dentures were fabricated for this patient to allow for prosthetically driven implant placement. 4 implants were placed interforaminally so that they were parallel to each other. If the patient had an existing satisfactory denture, that was delivered at least six months ago, it was evaluated for retention, fit, support, stability, occlusion and esthetics. New and old dentures were later used for constructing the scan appliances.

The patients were randomly assigned into two groups with an allocation ratio 1:1. Simple randomization was done by preparing sequentially-numbered, opaque, sealed envelopes, that contained two-times folded cards with the treatment group written inside. Accordingly, the patients were assigned either to group T (control treatment/ telescopic retained implant supported removable overdentures) or group S (test treatment/ screw retained implant supported fixed prosthesis).

The intervention arm : Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.

the control treatment: Once adequate fit of the framework of the hybrid prosthesis was achieved, the wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth.

Lack of blinding of the operator, the participants and the assessor (patient) due to the obvious dissimilarity between the treatment arms, could have created performance and assessment bias. In an attempt to decrease the performance bias, randomization was delayed until the abutments were connected. When the prosthesis was delivered to the patient, they were requested to answer OHIP-14 and patient satisfaction questionnaires 2 weeks after prosthetic insertion, then 3, 6 and 12 months later.

The aim of this RCT was to evaluate patient satisfaction and oral-health related quality of life in completely edentulous patients receiving removable implant overdentures versus fixed implant hybrid restorations.

Data were statistically described in terms of mean +/- standard deviation (+/- SD), median and range. Comparison of ordinal variables between the study groups was done using Mann Whitney U test for independent samples. Within group comparison of the ordinal data was done using Friedmann test to detect significant differences between time in periods. This was followed by Wilcoxon signed rank test for paired comparisons. Two sided p values less than 0.05 was considered statistically significant. Additionally, a correlation between relevant domains of the OHIP-14 and the patient satisfaction questionnaires was done using Spearman rank correlation test. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows

Studientyp

Interventionell

Einschreibung (Tatsächlich)

19

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Manial
      • Cairo, Manial, Ägypten, 12911
        • Faculty of Dentistry

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Inclusion Criteria:

  1. Completely edentulous male patients with an age range from 40- 70 years.
  2. Patients with a HbA1c equal to or less than 7
  3. All patients should have normal maxillo-mandibular relationship (Angle class I).
  4. Patients should have maxillary and mandibular ridges at least 7mm in width and 13 mm in height in the interforaminal areas and in the esthetic zones (premolar to premolar regions), respectively. This accommodated a pre-planned implant size of 3.7mm x 10 or 11mm.
  5. The maxillary and mandibular ridges should be covered by keratinized attached mucosa at least 5mm in width.
  6. An interarch space between the edentulous maxillary and mandibular ridges should not be less than 22 mm to accommodate the planned maxillary and mandibular implant-supported prostheses. This was confirmed by mounted diagnostic casts.
  7. Patients who were cooperative and who were psychologically and mentally stable as revealed from the initial interview with the patients were considered eligible.

Exclusion Criteria:

  • Females were excluded on purpose to prevent failures associated with osteoporosis and to avoid gender variability which definitely affects the results of patient satisfaction and OHIP.

    2. Patients requiring hard or, soft tissue grafting of the proposed implant sites.

    3. Heavy smokers (more than 10 cigarettes / day) or patients with para-functional habits like clenching or bruxism were excluded. This was important to decrease the risk of implant failure.

    4. Patients with temporo-mandibular joint disorders were considered ineligible because of the expected occlusal disturbances.

    5. Patients with systemic disease that might contra-indicate implants placement or affect osseointegration e.g. uncontrolled diabetes.

    6. Patients who took chemo-or radiotherapy or any drug that might counter-affect the healing process or the quality of bone.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Fixed implant supported prosthesis
the prosthesis is an all-on-four prosthesis composed of a hybrid prosthesis. a metal framework, acrylic resin denture base and acrylic resin teeth
Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin
Aktiver Komparator: Removable implant supported prosthesis
the prosthesis is an all-on-four prosthesis composed of a telescopic retained overdenture, both primary and secondary copings are custom made. the secondary copings are conncetd via a metal framework
The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
patient satisfaction
Zeitfenster: 2 weeks after prosthetic insertion- 1 year
questionnaire. The patient satisfaction questionnaire is composed of 14 questions concerned with esthetics, speech, mastication, operative and prosthetic procedures, incidence of complications, pre-operative instructions, total time interval, cost, operator, hygienic procedures, overall experience as well as the willingness to repeat or refer others for the procedure.
2 weeks after prosthetic insertion- 1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
oral health related quality of life
Zeitfenster: 2 weeks after prosthetic insertion- 1 year
OHIP-14 scoring
2 weeks after prosthetic insertion- 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Amira kheidr, masters, Cairo University
  • Studienleiter: Amr El Khadem, phd, Cairo University
  • Studienstuhl: Samira Ibrahim, phd, Cairo University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2017

Primärer Abschluss (Tatsächlich)

30. September 2018

Studienabschluss (Tatsächlich)

28. August 2019

Studienanmeldedaten

Zuerst eingereicht

24. Dezember 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Januar 2021

Zuerst gepostet (Tatsächlich)

5. Januar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 151017

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Völlig zahnlose Patienten

Abonnieren