Two-piece Versus Single-piece Patient-specific Titanium Subperiosteal Implants

NCT03242330 | Unknown DMC

• 1 other identifier: Cairo Uni
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to find out if there is a difference between single-piece and two-piece titanium patient-specific mandibular subperiosteal implants in terms of implant survival, patient satisfaction, and soft tissue dehiscence. This is to enhance both surgical and prosthetic outcomes for the sake of improved implant longevity, soft tissue health and patient well-being.

Conditions

Dental Implant

Keywords

Implant survival; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Implant survival

  Implant survival will be assessed by evaluation of the following criteria: a) Persistent pain, and/or b) mobility and/or c) persistent exudate In case of presence of one or more of the previously mentioned criteria, implants will be regarded non-survived. Presence of persistent pain either spontaneous or during function Presence of clinically detected mobility Evidence of infection in the form of pus formation or persistent inflammatory fluid exudate

  12 months (post-surgery)

Secondary Outcomes (4)

• Implant survival

  6 months (post-surgery)

• Implant survival

  3 months (post-surgery)

• Patient satisfaction

  At 1,3,6 and 12 months (after loading of final prosthesis)

• Soft tissue dehiscence

  At 1,3,6 and 12 months (post-surgery)

Study Arms (2)

Two-piece subperiosteal implant

EXPERIMENTAL

The two-piece subperiosteal implant will be designed with an internal connection that will receive its prosthetic counterpart later in the second stage surgery, which will retain the final prosthesis in place. Two-piece constructions allow for undisturbed submerged healing, without being exposed to the oral environment, achieved by attaining primary closure over the inserted implant body.

Device: Subperiosteal implant

Single-piece subperiosteal implant

ACTIVE COMPARATOR

The single-piece subperiosteal implant will be designed in the from of a framework with protruding posts that will appear penetrating through the mucosa, and will later carry the overlying superstructure (prosthesis). Single-piece subperiosteal implants do not require a second stage surgery.

Device: Subperiosteal implant

Interventions

Subperiosteal implant DEVICE

Subperiosteal implants are placed and fitted 'onto' the jaw bone just right below the mucoperiosteum; where the post of the metal frame is in a protruding position through the mucosa holding the prosthesis that will be later fitted.

Single-piece subperiosteal implant; Two-piece subperiosteal implant

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous male or female patients with atrophied mandibles between the ages of 50 to 75.
• Atrophic mandibular ridges in terms of width and height, impeding the possibility of placing a root form dental implant of at least 3mm in diameter and 8 mm in length.
• Completely edentulous patients (with the above mentioned criteria) who can't stand a soft-tissue supported mandibular denture.

You may not qualify if:

• Patients having a medical condition that absolutely contraindicates implant placement.
• Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
• Potentially uncooperative patients who are not willing to go through the proposed interventions.
• Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
• Patients who are satisfied with their soft-tissue supported mandibular denture.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

Related Publications (9)

• Sconzo J. The complete mandibular subperiosteal implant: an overview of its evolution. J Oral Implantol. 1998;24(1):14-5. doi: 10.1563/1548-1336(1998)242.0.CO;2. No abstract available.

  PMID: 9759036 BACKGROUND

• Burns DR, Unger JW, Elswick RK Jr, Beck DA. Prospective clinical evaluation of mandibular implant overdentures: Part I--Retention, stability, and tissue response. J Prosthet Dent. 1995 Apr;73(4):354-63. doi: 10.1016/s0022-3913(05)80331-2.

  PMID: 7783014 BACKGROUND

• Aras E, Sonmez M, Zora M, Basarir M, Kurtulmus H. The use of prefabricated titanium tissue abutments for the construction of a maxillary subperiosteal implant. J Oral Implantol. 2005;31(5):255-8. doi: 10.1563/1548-1336(2005)31[255:TUOPTT]2.0.CO;2.

  PMID: 16265856 BACKGROUND

• OBWEGESER HL. Experiences with subperiosteal implants. Oral Surg Oral Med Oral Pathol. 1959 Jul;12(7):777-86. doi: 10.1016/0030-4220(59)90027-1. No abstract available.

  PMID: 13674677 BACKGROUND

• The glossary of prosthodontic terms. J Prosthet Dent. 2005 Jul;94(1):10-92. doi: 10.1016/j.prosdent.2005.03.013. No abstract available.

  PMID: 16080238 BACKGROUND

• Weiss CM, Reynolds T. A collective conference on the utilization of subperiosteal implants in implant dentistry. J Oral Implantol. 2000;26(2):127-8. doi: 10.1563/1548-1336(2000)262.0.CO;2. No abstract available.

  PMID: 11831330 BACKGROUND

• Falomo OO, Hobkirk JA. A retrospective survey of patients treated with subperiosteal and endosseous implants. J Prosthet Dent. 1988 Nov;60(5):587-90. doi: 10.1016/0022-3913(88)90219-3. No abstract available.

  PMID: 3058941 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

• Juodzbalys, G., M. Sapragoniene, and A. Wennerberg, New acid etched titanium dental implant surface. Stomatologija-Baltic Dental and Maxillofacial Journal, 2003. 5: p. 101-105.

  BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Dental Implantation, Subperiosteal

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Mariam A. Roshdy

  Assistant lecturer, Department of Prosthodontics, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: After assignment to interventions, blinding of trial participants, care providers and outcome assessors is not applicable. Data analysts will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, Department of Prosthodontics, Faculty of Oral and Dental Medicine, Cairo University

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 8, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)