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Completed

NCT Number: NCT06866860

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

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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Key information

Conditions

Dental Implant

Age range

20 year–50 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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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

Primary outcomes

  1. change in implant stability

    Time frame: Baseline and 4 months

    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

  2. change in postoperative oedema

    Time frame: 2nd day, 1 week and 2 weeks

    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).

Secondary outcomes

  1. Presence of intra or postoperative complications

    Time frame: 4 months

    Bone overheating. Bone fenestration. Wound dehiscence. Peri-implantitis.

  2. change in crestal bone loss

    Time frame: baseline and 4 months

    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.

  3. change in bone density

    Time frame: baseline and 4 months

    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).

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

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.

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