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Completed

NCT Number: NCT04386382

Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement

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.

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Key information

Conditions

Anterior Maxillary Narrow Ridge

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ridge splitting flapless technique using interchangeable guide followed by implant placement

Procedure

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

Primary outcomes

  1. Clinical evaluaion

    Time frame: After 1 week

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

  2. Postoperative Pain

    Time frame: After 1 week

    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.

  3. 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

Secondary outcomes

  1. operation time

    Time frame: During the procedure

    Evaluation of the operating time

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.