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

Evaluation of Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants in Mandibular Posterior Region (Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Other: Implant surgical guide with internal irrigation; Other: Conventional implant surgical guide with external irrigation

• Study Type: Interventional
• Enrollment (Actual): 14
• 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: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	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
Experimental: Study group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in implant stability	Osstell will be used to objectively and non-invasively determine implant stability and to assess the progress of osseointegration without jeopardizing the healing process. This method is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant	Baseline and 4 months
change in postoperative oedema	This will be measured as follows: None (no inflammation). Mild (intraoral swelling confined to the surgical field). Moderate (extraoral swelling in the surgical zone). Severe (extraoral swelling spreading beyond the surgical zone).	2nd day, 1 week and 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of intra or postoperative complications	Bone overheating. Bone fenestration. Wound dehiscence. Peri-implantitis.	4 months
change in crestal bone loss	A CBCT was obtained immediately post operatively T1 and after 4 months T2 and evaluated using (BlueSky plan, BlueSky Bio, USA) to asses Crestal bone loss.	baseline and 4 months
change in bone density	A CBCT was obtained immediately post operatively T1 and after 4 months T2 and evaluated using (BlueSky plan, BlueSky Bio, USA) to asses Bone density using Hounsfield Unit (HU).	baseline and 4 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0810-12/2023

Drug and device information, study documents

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