Dental ImplantNCT06866860
Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants
A study testing Implant surgical guide with internal irrigation and Conventional implant surgical guide with external irrigation in people with Dental Implant, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dental Implant
- What is being tested?
- Implant surgical guide with internal irrigation and Conventional implant surgical guide with external irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2024to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official 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)
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
- Being tested
- Implant surgical guide with internal irrigation, Conventional implant surgical guide with external irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgical guide with internal irrigationOther
- 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 irrigationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Implant surgical guide with internal irrigation |
| Control group | Active comparator | Not described Receives: Other: Conventional implant surgical guide with external irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 2nd day, 1 week and 2 weeks
Secondary outcomes (3)
Presence of intra or postoperative complications
Bone overheating. Bone fenestration. Wound dehiscence. Peri-implantitis.
Measured: 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.
Measured: 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).
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start4 Apr 2024
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866860
- Sponsor's protocol ID
- 0810-12/2023
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06866860
- Acronym / sponsor ID
- 0810-12/2023
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Implant surgical guide with internal irrigation |
| Control group | Active comparator | Other: Conventional implant surgical guide with external irrigation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study group |
| Conventional implant surgical guide with external irrigationVirtual 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 | Other | Control group |
Primary outcome
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
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).
3 secondary outcomes
Presence of intra or postoperative complications
Time frame: 4 months
change in crestal bone loss
Time frame: baseline and 4 months
change in bone density
Time frame: baseline and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant surgical guide with internal irrigation and Conventional implant surgical guide with external irrigation in people with Dental Implant, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in implant stability (time frame: Baseline and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.