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Completed

NCT Number: NCT03866031

Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants

3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.

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Key information

Conditions

Problem With Dentures

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Removable prosthodontics department and implantation department / Faculty of dental medicine / Damascus univ

Damascus, Syria

About this study

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

The evaluations of the primary outcomes will be conducted before implantation and after (1 - 3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after (0 - 3 - 6 - 12 - 18).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the patient should be completely edentulous for at least 6 months.
  • first class jaw relation.
  • adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm.
  • the patients should be able to speak and write in arabic.

Exclusion criteria

  • patients who received radiotherapy to the head or neck region for tumors. (2) a history of chemotherapy. (3) patients on long-term steroids, or bisphosphonates. (4) heavy smokers. (5) patients with physical and mental dis -abilities that interfere with the maintenance of implants.

(6) uncontrolled systematic disease that could compromise implant surgery. (7) extreme bruxism. (8) infectious disease. (9) temporomandibular joint dysfunction.

Treatment and study plan

implant-supported mandibular overdenture

Other

The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.

Primary outcomes

  1. change in denture stability

    Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded

    The evaluation will be by Digital force gauge, a Hook of orthodontic wire (18 gauge diameter) will attach to the labial flange of overdenture, the other end of wire will connect to the force gauge which will be pull vertically upward until denture retention lost, and then reading will record 3 times and means value will calculate.

  2. change in masticatory efficiency

    Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded

    The evaluation will be by test food filtering device,Where the subjects will chew a measured portion of test food (peanuts) for 20 strokes. The test food will strain through mesh sieve (2 mm opening). The volume of food remaining on the sieve and that passing through the sieve determined the masticatory performance.

  3. change in patient's satisfaction

    Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded

    The evaluation will be by 100 mm Visual Analog Scale (VAS), for which higher scores indicate greater satisfaction, They will be asked to rate their level of comfort, ability to chew, stability, ability to speak, ease of cleaning their prostheses and their general satisfaction.

  4. change in oral health related quality of life

    Time frame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded

    The evaluation will be by oral health impact profile of edentulous (Ohip-Edent) instrument, Patients will answer questions of ohip-edent which included 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, Psychological disability, Social disability, Handicap. Responses will made on a five-grade Likert-type scale:

    0=never ; 1=hardly ever ; 2=occasionally ; 3= fairly often ; 4= very often. disability, social disability and handicap

  5. change in Peri-implant crestal alveolar bone loss

    Time frame: T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded

    The evaluation will be by panoramic radiogram, Peri-implant vertical and horizontal alveolar bone loss will measure (in mm) at the mesial and distal surface of each implant.

    implant

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 7, 2019
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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