Patient's Satisfaction of Mandibular Implant Supported Overdentures With Reduced Denture Base Extensions.

NCT06850558 | Completed

• 1 other identifier: A08011024RP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare reduced (partially extended) denture bases with fully extended bases regarding patient satisfaction, oral health-related quality of life (OHRQoL), and masticatory efficiency. A within-subject study design was carried out; involving 20 completely edentulous participants aged 50-75 years, who received newly constructed conventional complete denture. Four parallel implants were installed in the interforaminal region, implant overdenture (IOD) retained by bar attachment was constructed for each patient and were provided with two different overdenture designs: (1)firstly a fully extended denture base (FIOD) (2) then a reduced (partially extended) denture base (RIOD). Each patient allowed to wear each types of overdentures for a period of 3 months prior to evaluation. The following outcome measures were assessed: Patient satisfaction, the Oral Health Impact Profile (OHIP-14), and Chewing efficiency were assessed.

Conditions

Patient Satisfaction Using Implant Retained Overdentures

Keywords

Mandibular implant overdentures y; Reduced denture base; Patient satisfaction; oral health-related quality of life; Masticatory efficiency

Outcome Measures

Primary Outcomes (2)

• I- Patient satisfaction

  Patient satisfaction was assessed using a questionnaire based on visual analog scale (VAS). Satisfaction was tested concerning comfort, esthetics, stability, speaking retention, general satisfaction. Patients were requested to mark their answer (amount of satisfaction) on a 100-mm line (with zero indicates not satisfied at all and 100 indicates to completely satisfied). Higher VAS scores showed high satisfaction and lower scores indicated low satisfaction. The mean of the answers (length of the lines from zero to the marks in mm) for every question was subjected to statistical analysis. All dimensions of this instrument were highly associated with the items of general satisfaction (Awad \& Feine, 1998). The questionnaire was represented to the patients in Arabic

  3 months after each treatment

• The oral health-related quality of life

  The oral health-related quality of life (OHRQoL) was assessed using the OHIP-14 oral health impact profile questionnaire, which consists of 7 categories: functional limitation, physical disability, physical pain

  3 months after each treatment

Secondary Outcomes (1)

• Masticatory (chewing) efficiency

  3 months after each treatment

Study Arms (2)

fully extended denture base

ACTIVE COMPARATOR

Patient allowed to wear fully extended overdenture base for a period of 3 months prior to evaluation after implants installation (four parallel implants) in the interforaminal region.

Procedure: Four parallel implants were installed in the interforaminal region

partially extended denture base

ACTIVE COMPARATOR

Patient allowed to wear partially (reduced) extended overdenture base for a period of 3 months prior to evaluation after implants installation (four parallel implants) in the interforaminal region.

Procedure: Four parallel implants were installed in the interforaminal region

Interventions

Four parallel implants were installed in the interforaminal region PROCEDURE

All participants administrated prophylactic antibiotics one day before implant placement and continued 7 days after surgery. Participants were asked to rinse their mouth with chlorhexidine mouthwash just before surgery and 7 days after surgery. Under local anesthesia, four implants were placed bilaterally in the interforaminal region. Four parallel implants (TioLogic, Dentaurum) were inserted in the inter-foraminal area using the submerged surgical approach and delayed loading protocol. By using the stereolithographic surgical guide the Implants were installed by the same surgeon with a minimum torque of 35 Ncm to give high initial stability. Relief was done in the mandibular denture over the implants and tissue conditioner (Visco-gel; DENTSPLY, Weybridge, UK) was used as a relining material. osseointegration was allowed to occur for a period of 3-6 months prior to final restoration.

Also known as: Device (four titanium implant fixtures using submerged technique for implant installation protocol))

fully extended denture base; partially extended denture base

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 75 years.
• Completely edentulous mandibular arch with adequate bone volume (≥10 mm in height and ≥ 6 mm in width at the implant site) and density to allow placement of 4 osseointegrated implants in the interforaminal region.
• Good general health, with no history of systemic diseases that would contraindicate implant placement or the use of overdentures.
• Presence of sufficient inter-arch space for overdenture construction and implant placement.
• No history of severe bruxism or parafunctional habits that could affect implant stability or prosthetic outcomes.
• Ability to understand and complete questionnaires regarding patient satisfaction and quality of life.
• Willingness to comply with the study protocol and attending follow-up visits.

You may not qualify if:

• History of temporomandibular joint disorders.
• Neurological disorders affecting masticatory function.
• Presence of uncontrolled systemic diseases.
• Cognitive impairments affecting the ability to provide informed consent.
• Severe bone resorption or contraindications for implant placement (e.g., insufficient ridge height or width).
• Presence of systemic diseases affecting oral health (e.g., uncontrolled diabetes, systemic inflammatory disorders).
• Inability to wear dentures for extended periods or intolerance to the study protocol
• \. Inability to wear dentures for extended periods or intolerance to the study protocol

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Removable prosthodontics department,Faculty of dentistry,Mansoura university, #68 ElGomhoria Street, ElMansoura, Egypt.

Al Mansurah, Eldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohamed E Elgamal, PhD

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Abdallah M Ibrahim, PhD

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of prosthodontics

Model Details: A within-subject study design was carried out; involving 20 completely edentulous participants aged 50-75 years, who received newly constructed conventional complete denture., implant overdenture (IOD) retained by bar attachment was constructed for each patient and were provided with two different overdenture designs: (1) firstly a fully extended denture base (FIOD) (2) then a reduced (partially extended) denture base (RIOD). Each patient allowed to wear each types of overdentures for a period of 3 months prior to evaluation.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 27, 2025
• Study Start: January 4, 2024
• Primary Completion: January 5, 2025
• Study Completion: February 14, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)