Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05843331
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Implant Complication; Bone Loss	Procedure: implants	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vertical Implant Versus Inclined Implant to Retain Locator Maxillary Overdenture : One Year Randomized Controlled Clinical Trial
• Actual Study Start Date: Jan 15, 2022
• Actual Primary Completion Date: Mar 25, 2023
• Actual Study Completion Date: Apr 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: posterior vertical implants the anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted vertically just anterior to the maxillary sinus (in the area of second premolars) .	Procedure: implants; Four implants in the maxilla with locator attachments
Active Comparator: posterior inclined implants The anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's and will be inclined 15o labially following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted just anterior to the maxillary sinus (in the area of second premolars) and inclined 15o distally .	Procedure: implants; Four implants in the maxilla with locator attachments

Outcome Measures

Primary Outcome Measures

1. plaque index [12 months]

   measure plaque around each implant using Mombelli indices

2. pocket depth [12 months]

   dental probe used to measure the depth of formed pocket around each implant

3. implant stability [12 months]

   stability of each implant measured using Osstell® device

Secondary Outcome Measures

1. Radiographic outcome [12 months]

   measuring bone resorption using the long-cone standardized periapical radiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 58 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Unable to wear the upper denture

2. Radiographic diagnosis of bone loss

Exclusion Criteria:

1. Neuromuscular diseases

2. Insulin dependent diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university	Mansoura		Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Marwa Aboelez, Phd, Mansoura University
• Study Chair: Mostafa Elsyad, Phd, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT05843331
• Other Study ID Numbers: A26060722
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mansoura University: maxillary overdentures; angled abutment; locator

Study Results

No Results Posted as of May 6, 2023