Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2024-10-17

Brief Summary

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Background: Patient specific surgical guides (PSG) have been widely used to achieve a precise 3D implant position. However, they prevent external cooling systems from reaching the osteotomy site sufficiently. So, heat generated during guided implant surgery is greater than free hand technique. Adding internal irrigation channel to the conventional surgical guides allows better diffusion of irrigation to the osteotomy site and reduces heat generation.

Aim of the study: Is to introduce a patient specific surgical guide design with internal irrigation system and compare it to the conventional surgical guide with external irrigation clinically through bone temperature, implant stability and radiographically by CBCT through crestal bone loss and bone density.

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Detailed Description

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Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Group Type EXPERIMENTAL

Implant surgical guide with internal irrigation

Intervention Type OTHER

* Virtual surgical plan will be completed in the implant planning software (BlueSky plan, BlueSky Bio, USA), and the implant type, position, and sleeve height will be adjusted.
* The entry point of the surgical drill into the alveolar bone will be identified.
* An irrigation channel will be added, directed toward the entry point of the drill and adjusted to have the same diameter as the irrigation system tube.

Control group

Group Type ACTIVE_COMPARATOR

Conventional implant surgical guide with external irrigation

Intervention Type OTHER

Virtual surgical plan will be completed in the implant planning software (BlueSky plan, BlueSky Bio, USA), and the implant type, position, and sleeve height will be adjusted. Conventional guide will be printed

Interventions

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Implant surgical guide with internal irrigation

* Virtual surgical plan will be completed in the implant planning software (BlueSky plan, BlueSky Bio, USA), and the implant type, position, and sleeve height will be adjusted.
* The entry point of the surgical drill into the alveolar bone will be identified.
* An irrigation channel will be added, directed toward the entry point of the drill and adjusted to have the same diameter as the irrigation system tube.

Intervention Type OTHER

Conventional implant surgical guide with external irrigation

Virtual surgical plan will be completed in the implant planning software (BlueSky plan, BlueSky Bio, USA), and the implant type, position, and sleeve height will be adjusted. Conventional guide will be printed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with missing mandibular posterior premolar or molar teeth.
* Tooth extraction at the implant sites was performed at least 4 months before the surgery.
* Residual alveolar bone height more than 10 mm.
* With minimum alveolar bucco-lingual dimension of 6 mm.
* Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.

Exclusion Criteria

* Severe atrophic alveolar ridge (height less than 10mm, width less than 6mm).
* Bad oral hygiene ( Silness-Löe index (score 2-3).
* Heavy smoker (smoke greater than or equal 25 cigarettes per day).
* Presence of acute infections or periapical lesions in adjacent teeth.
* Parafunctional habits.
* Pregnant females.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No