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

Problem With Dentures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866031
• Other study ID #: UDDS-RemPro-01-2019
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: December 12, 2022

Study information

• Verified date: February 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 12, 2022
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

1. the patient should be completely edentulous for at least 6 months.

2. first class jaw relation.

3. adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm.

4. the patients should be able to speak and write in arabic. Exclusion Criteria: 1) 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.

Related Conditions & MeSH terms

• Problem With Dentures

Intervention

Other:
• implant-supported mandibular overdenture
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.

Locations

Country	Name	City	State
Syrian Arab Republic	Removable prosthodontics department and implantation department / Faculty of dental medicine / Damascus univ	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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