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

NCT06866860 | Completed

• 1 other identifier: 0810-12/2023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Presence of intra or postoperative complications

  4 months

• change in crestal bone loss

  baseline and 4 months

• change in bone density

  baseline and 4 months

Study Arms (2)

Study group

EXPERIMENTAL

Other: Implant surgical guide with internal irrigation

Control group

ACTIVE COMPARATOR

Other: Conventional implant surgical guide with external irrigation

Interventions

Implant surgical guide with internal irrigation 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.

Study group

Conventional implant surgical guide with external irrigation 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

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 10, 2025
• Study Start: April 4, 2024
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

EG (1)