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

NCT03866031 | Completed DMC

• 1 other identifier: UDDS-RemPro-01-2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Problem With Dentures

Keywords

Implant, overdenture, Immediate loading

Outcome Measures

Primary Outcomes (5)

• change in denture stability

  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.

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

• change in masticatory efficiency

  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.

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

• change in patient's satisfaction

  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.

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

• change in oral health related quality of life

  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

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

• change in Peri-implant crestal alveolar bone loss

  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

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

Study Arms (3)

M:2.75

EXPERIMENTAL

12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm

Other: implant-supported mandibular overdenture

M3.25

EXPERIMENTAL

12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm

Other: implant-supported mandibular overdenture

S3.75

EXPERIMENTAL

12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm

Other: implant-supported mandibular overdenture

Interventions

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.

M3.25; M:2.75; S3.75

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, Syria

Location

Related Publications (5)

• Zygogiannis K, Aartman IH, Parsa A, Tahmaseb A, Wismeijer D. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1377-1388. doi: 10.11607/jomi.5981.

  PMID: 29140382 BACKGROUND

• Kanazawa M, Tanoue M, Miyayasu A, Takeshita S, Sato D, Asami M, Lam TV, Thu KM, Oda K, Komagamine Y, Minakuchi S, Feine J. The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial. Medicine (Baltimore). 2018 May;97(20):e10721. doi: 10.1097/MD.0000000000010721.

  PMID: 29768340 BACKGROUND

• ALHarthi SS, BinShabaib MS, Ahmed HB, Mehmood A, Khan J, Javed F. Comparison of peri-implant clinical and radiographic inflammatory parameters among cigarette and waterpipe (narghile) smokers and never-smokers. J Periodontol. 2018 Feb;89(2):213-218. doi: 10.1902/jop.2017.170358.

  PMID: 28777038 BACKGROUND

• Kappel S, Giannakopoulos NN, Eberhard L, Rammelsberg P, Eiffler C. Immediate Loading of Dental Implants in Edentulous Mandibles by Use of Locator(R) Attachments or Dolder(R) Bars: Two-Year Results from a Prospective Randomized Clinical Study. Clin Implant Dent Relat Res. 2016 Aug;18(4):752-61. doi: 10.1111/cid.12349. Epub 2015 May 7.

  PMID: 25950679 BACKGROUND

• Kroll P, Hou L, Radaideh H, Sharifi N, Han PP, Mulligan R, Enciso R. Oral Health-Related Outcomes in Edentulous Patients Treated With Mandibular Implant-Retained Dentures Versus Complete Dentures: Systematic Review With Meta-Analyses. J Oral Implantol. 2018 Aug;44(4):313-324. doi: 10.1563/aaid-joi-D-17-00210. Epub 2018 Feb 19.

  PMID: 29457932 BACKGROUND

Study Officials

• Heba M Moftah, DDS MSc

  PhD student at Removable Prosthodontics Department, faculty of dental medicine, Damascus Univ

  PRINCIPAL INVESTIGATOR

• Mohannad H Al-saadi, DDS MSc PhD

  Professor of Removable Prosthodontics, faculty of dental medicine, Damascus Univ

  STUDY DIRECTOR

• Khaldoun A Darwich, DDS Msc PhD

  Professor of Oral and Maxillofacial surgery, faculty of dental medicine, Damascus Univ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 7, 2019
• Study Start: April 3, 2019
• Primary Completion: June 20, 2021
• Study Completion: December 12, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)