Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Maxillary Narrow Ridge
• Intervention / Treatment: Procedure: ridge splitting flapless technique using interchangeable guide followed by implant placement

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ridge splitting flapless technique using interchangeable guide; 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.

Procedure: ridge splitting flapless technique using interchangeable guide followed by implant placement; An informed consent is taken from all the patients I. Presurgical phase: Proper dental and medical history.; Scaling and oral hygiene measurements.; Clinical examination.; Radiographic examination. Clinical bucco-lingual measurements was done using calipers to ensure the patients would meet our initial inclusion criteria prior to further investigations. III. Fabrication of interchangeable surgical guide stent from primary impression: Optical scanning of the dental casts was done using Ceramill map 400; surgical stent was 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. All patients will be operated under local anesthesia, stent was placed on ridge and adapted well after disinfection osteotomy was done using piezotome splitting tips Implant-insertion was started immediately

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluaion	post operative complication (presence or absence of any sign of swelling or infection)	After 1 week
Postoperative Pain	Visual Analouge Scale (VAS) 0=no pain; mild pain; it is easily tolerated; moderate pain; it is causing discomfort but bearable.; severe pain; it is causing discomfort, hardly tolerated and unbearable.	After 1 week
Change of bone width from baseline measurements	Cone beam computed tomography (CBCT) was used to evaluate bone width and density to all patients by doing CBCT at time intervals	Baseline, 1 week, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	Evaluation of the operating time	During the procedure

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Ridge splitting

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No