Clinical trial NCT05843331: Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture
Official title: Vertical Implant Versus Inclined Implant to Retain Locator Maxillary Overdenture : One Year Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Complication
Bone Loss
Keywords: maxillary overdentures
angled abutment
locator
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 58
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial study conducted on 12 participants with completely edentulous maxillary ridges. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 participants (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. A new maxillary conventional dentures will be constructed with a bilateral balanced occlusal concept for all patients. Maxillary dentures were duplicated into heat cure acrylic resin dentures to be used as a radiographic template. Four implants were inserted in the maxilla . For both groups, locator abutments were screwed to the abutments .Clinical and radiographic evaluations were done.
Primary purpose: TREATMENT

Brief summary: Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures. There were two groups : 1) The control group 2) The study group

Detailed description: the aim of the present investigation was to evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures.

Materials and Methods conducted on 12 patients (6 males and 6 females) aged 58 to 68 years with completely edentulous maxillary ridges opposing implant-retained mandibular overdentures. Patients admit to the prosthodontic department, Faculty of Dentistry, Mansoura University for oral rehabilitation by implant-supported maxillary prostheses. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 patients (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. Randomization and allocation of patients into treatment groups was made by dental personnel who is blind to treatment groups.

Eligibility criteria: Inclusion Criteria:

1. Unable to wear the upper denture
2. Radiographic diagnosis of bone loss

Exclusion Criteria:

1. Neuromuscular diseases
2. Insulin dependent diabetes

Primary outcomes:
measure: plaque index
timeFrame: 12 months
measure: pocket depth
timeFrame: 12 months
measure: implant stability
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Mansoura University
name: Marwa Aboelez, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mostafa Elsyad, Phd
role: STUDY_CHAIR
References:
citation: ELsyad MA, Emera RM, Ashmawy TM. Effect of Distal Implant Inclination on Dislodging Forces of Different Locator Attachments Used for Mandibular Overdentures: An In Vitro Study. J Prosthodont. 2019 Feb;28(2):e666-e674. doi: 10.1111/jopr.12710. Epub 2017 Nov 16.
citation: ELsyad MA, Abo Hatem OE, Shawky AF, Emera RMK. Effect of Different Degrees of Mesial Implant Inclination on the Retention and Stability of Two-Implant Mandibular Overdentures Retained with Stud Attachments: An In Vitro Study. Int J Oral Maxillofac Implants. 2018 March/April;33(2):259-268. doi: 10.11607/jomi.5791. Epub 2017 Oct 13.