Clinical trial NCT03866031: Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants
Official title: Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem With Dentures
Keywords: Implant, overdenture, Immediate loading
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: change in denture stability
timeFrame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
measure: change in masticatory efficiency
timeFrame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
measure: change in patient's satisfaction
timeFrame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
measure: change in oral health related quality of life
timeFrame: T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded
measure: change in Peri-implant crestal alveolar bone loss
timeFrame: T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Removable prosthodontics department and implantation department / Faculty of dental medicine / Damascus univ
Study officials:
affiliation: PhD student at Removable Prosthodontics Department, faculty of dental medicine, Damascus Univ
name: Heba M Moftah, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Removable Prosthodontics, faculty of dental medicine, Damascus Univ
name: Mohannad H Al-saadi, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Professor of Oral and Maxillofacial surgery, faculty of dental medicine, Damascus Univ
name: Khaldoun A Darwich, DDS Msc PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.
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.