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Clinical Trials/NCT02952274
NCT02952274UnknownNot Applicable

Comparison Between Ball and Locator Attachments in Patients Receiving Complete Mandibular Overdenture Retained by Single Midline Implant

Cairo University0 sites22 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
22
Primary Endpoint
OHRQoL (oral health related quality of life)

Study Overview

Brief Summary

The aim of this study is to compare the ball attachment to the locator attachment regarding the OHRQoL (oral health related quality of life) for completely edentulous patients retaining a mandibular overdenture with a midline placed implant

Detailed Description

The selected patients will be informed of the nature of the research work and informed consent will be obtained for each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups.

Conventional upper and lower complete dentures will be constructed before installing the implant where the lower denture will be duplicated into a radiographic stent. CBCT (cone beam computerized tomography) with lower radiographic stent in place stabilized with the upper denture using a rubber base index, will be taken to know the available bone height &width to determine the optimum implant size.

Patients will receive single implant in symphyseal region of mandible. The surgical procedure is carried out under local anaesthesia, following premedication with 2 g amoxicillin (or 600mg of clindamycin) and 1 g paracetamol. After two rinses with 0.2% chlorhexidine gluconate, each lasting 1 min, the labial and lingual mucosa of the anterior mandible is locally infiltrated with 2.2 ml of mepivacaine 2% with 1 : 100,000 adrenalin. The surgical guide made from the duplicated mandibular complete denture is used to mark the implant site.

A crestal incision will be performed and a full-thickness mucoperiosteal flap is raised to expose the anterior mandible. Deep dissection of this flap lingually exposes the cortical plate of the mandible and any lingual concavities. Sequential drilling & implant placement will be the next step. The implant position is adjusted to the midline of the mandible and optimum labiolingual positioning and bone levelling is performed as necessary.

A healing abutment is selected to be 2mm above the mucosa. The mucosa is adjusted and sutured with interrupted sutures (3-0 silk). Postoperatively, the patient should rinse with 0.2% chlorhexidine gluconate mouthwash for 2 weeks. Immediately following implant surgery, generous relief of the existing mandibular complete denture is carried out and a tissue conditioner is applied to the undersurface of the denture. The patient leaves after the surgical operation wearing both the complete maxillary denture opposed by the tissue-conditioned mandibular complete denture. A period of 8 weeks will be allowed for healing and osseointegration.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Completely edentulous patient
  • •Patients having enough bone for an implant length of at least 10 mm
  • •No apparent bony mal-relation.
  • •No intraoral soft and hard tissue pathology
  • •No uncontrolled systematic diseases such as hypertension, diabetes and immunodeficiency.

Exclusion Criteria

  • •Drug or alcohol abuse,
  • •A health condition precluding surgery,
  • •Physical reasons that could affect follow-up,
  • •Psychiatric problems,
  • •Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.

Arms & Interventions

locater attachment

Active Comparator

mandibular overdenture retained with single midline implant using locator attachment

Intervention: mandibular overdenture retained with single midline implant using locator attachment (Device)

ball attachment

Active Comparator

mandibular overdenture retained with single midline implant using ball attachment

Intervention: mandibular overdenture retained with single midline implant using ball attachment (Device)

Outcomes

Primary Outcomes

OHRQoL (oral health related quality of life)

Time Frame: 6 months

Secondary Outcomes

  • Peri-implant Probing Depth(6 months)
  • Peri-implant Plaque index(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Hussein El-Baz

Dr.

Cairo University

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