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Clinical Trials/NCT04386382
NCT04386382CompletedNot Applicable

Evaluation of Interchangeable Guide in Flapless Ridge Splitting With Simultaneous Implant Placement (Clinical Study)

Hams Hamed Abdelrahman1 site in 1 country8 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
Postoperative Pain

Study Overview

Brief Summary

A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.

Detailed Description

A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients with anterior maxillary narrow ridge
  • •Patients with adequate alveolar ridge bone height
  • •Age ranging from 20-40 years.
  • •Patients should have adequate oral hygiene
  • •Patients should be free of soft tissue or oral dental pathology
  • •Patients who accept to participate in the study.

Exclusion Criteria

  • •Patients suffering from relevant systemic and/or metabolic diseases
  • •Patients suffering from immunosuppressive and/or autoimmune diseases
  • •Heavy smokers.

Arms & Interventions

ridge splitting flapless technique using interchangeable guide

Experimental

Fabrication of interchangeable surgical guide stent:

  • Optical scanning of the dental casts was done using Ceramill map 400
  • The treatment plan and the surgical stent were designed using Mimics Innovation Suite 19 ™ software
  • Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique.

Intervention: ridge splitting flapless technique using interchangeable guide followed by implant placement (Procedure)

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: After 1 week

Visual Analouge Scale (VAS) 0=no pain 1. mild pain; it is easily tolerated 2. moderate pain; it is causing discomfort but bearable. 3. severe pain; it is causing discomfort, hardly tolerated and unbearable.

Change of bone width from baseline measurements

Time Frame: Baseline, 1 week, 3 months and 6 months

Cone beam computed tomography (CBCT) was used to evaluate bone width and density to all patients by doing CBCT at time intervals

Clinical evaluaion

Time Frame: After 1 week

post operative complication (presence or absence of any sign of swelling or infection)

Secondary Outcomes

  • operation time(During the procedure)

Investigators

Sponsor
Hams Hamed Abdelrahman
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer

Alexandria University

Study Sites (1)

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