Implant Stability and OsseointegrationlaserNCT07534826
Osseo Densification Technique and LLLT in DD Implant
A study testing implant placement using Densah burs and implantation using Densah burs with Laser biostimulation in people with Implant Stability and Osseointegration and Laser Effect Around Dental Implant, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
A comparative clinical study on 16 patients with Type IV bone, divided into two groups (n=8): implants placed using Densah burs only versus Densah burs combined with laser bio stimulation, to evaluate implant stability and healing. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Implant Stability and Osseointegration, Laser Effect Around Dental Implant
- What is being tested?
- implant placement using Densah burs and implantation using Densah burs with Laser biostimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2023to 1 Apr 2026
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Missing premolar and molar maxillary area with type IV bone density, (based on CBCT and number of Hounsfield units (HU).
- Patients age should be in the range from 30 up to 60 years old.
- Free from any systemic conditions and no previous drug affect bone metabolism.
Who cannot join
- Smoking
- Pregnant women
- Patients in variation in anatomical landmarks
- Patients with psychological problems
- Patients with bad oral hygiene
- Patients with parafunction habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine for Girls AlAzhar university
Cairo, 12345
About this study
Official title: Clinical and Radiographic Evaluation of Osseo Densification Technique Individually or Combined With Low Level Laser in Delayed Dental Implant Type IV Bone: Randomized Controlled Clinical Trial
A comparative clinical study on 16 patients with Type IV bone, divided into two groups (n=8): implants placed using Densah burs only versus Densah burs combined with laser bio stimulation, to evaluate implant stability and healing.
Read the detailed description
This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each).
- Group 1: Implant placement using Densah burs only.
- Group 2: Implant placement using Densah burs combined with laser bio stimulation. Both groups were selected with Type IV bone
- Being tested
- implant placement using Densah burs, implantation using Densah burs with Laser biostimulation
- Keywords
- dental implant, Osseodensification, Low-Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placement using Densah bursProcedure or surgery
Using only Densah burs
implantation using Densah burs with Laser biostimulationProcedure or surgery
laser was used combined with Densah burs during implantation
| Study group | Role | What they receive |
|---|---|---|
| Implant placement using Densah burs only | Active comparator | all patient's surgeries to receive dental implants were placed using only Densah burs, all patients were selected with type IV Bone. Device used was Densah kit system Receives: Procedure: implant placement using Densah burs |
| Implant placement using Densah burs combined with Laser biostimulation | Experimental | Surgeries for Implant placement using Densah burs combined with Laser biostimulation Using Densah Kit system as a devices and Low level laser biostimulation Receives: Procedure: implantation using Densah burs with Laser biostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate primary implant stability
Immediate primary implant stability was assessed through the measurement of insertion torque. The unit of measurement is (N.cm)
Measured: immediately
Secondary outcomes (4)
Implant stability and ossification
After 6 months following up it was measured clinically using osstell
Measured: 6 months follow up
Modified Plaque Index
Recorded at 4 surfaces per implant (Mesial, distal, buccal \& lingual) and expressed as Mean value With scoring (0-3) 0= No Plaque, 1= plaque detected by probe, 2= visible plaque, 3= abundant plaque.
Measured: after 12 months following up.
Probing depth
PD measured at 6 sites per implant using a calibrated periodontal probe and expressed in mm (mean value).
Measured: after 12 months following up.
Modified gingival index
MGI assessed at four sites per implant and averaged. Scoring (0-3); 0= normal, 1= mild inflammation, 2= moderate inflammation, 3= severe bleeding tendency.
Measured: after 12 months following up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Oct 2023
- Primary completion20 Nov 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Stability and OsseointegrationStudies 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
- Model description
- This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each). * Group 1: Implant placement using Densah burs only. * Group 2: Implant placement using Densah burs combined with laser biostimulation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doaa Mohammad Bhgaat, Faculty of Dental Medicine for Girls
- Investigators
- Etimad Ah shoreibah, professor, Study chair, prof. of oral medicine, periodontology, Diagnosis and radiologylobna mo abdelaziz, lecturer, Study director, lacturer of oral medicine, perio, diagnosis and radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534826
- Sponsor's protocol ID
- OMPDR 103-2j
- Acronym
- laser
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: results telling which group has better healing and stability
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Osseo Densification Technique Individually or Combined With Low Level Laser in Delayed Dental Implant Type IV Bone: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07534826
- Acronym / sponsor ID
- laser / OMPDR 103-2j
- Keywords
- dental implant, Osseodensification, Low-Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 16 Apr 2026 (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.
A comparative clinical study on 16 patients with Type IV bone, divided into two groups (n=8): implants placed using Densah burs only versus Densah burs combined with laser bio stimulation, to evaluate implant stability and healing.
Detailed description
This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each).
- Group 1: Implant placement using Densah burs only.
- Group 2: Implant placement using Densah burs combined with laser bio stimulation. Both groups were selected with Type IV bone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each). * Group 1: Implant placement using Densah burs only. * Group 2: Implant placement using Densah burs combined with laser biostimulation.
| Arm | Type | Receives |
|---|---|---|
| Implant placement using Densah burs only | Active comparator | Procedure: implant placement using Densah bursall patient's surgeries to receive dental implants were placed using only Densah burs, all patients were selected with type IV Bone. Device used was Densah kit system |
| Implant placement using Densah burs combined with Laser biostimulation | Experimental | Procedure: implantation using Densah burs with Laser biostimulationSurgeries for Implant placement using Densah burs combined with Laser biostimulation Using Densah Kit system as a devices and Low level laser biostimulation |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Missing premolar and molar maxillary area with type IV bone density, (based on CBCT and number of Hounsfield units (HU).
- Patients age should be in the range from 30 up to 60 years old.
- Free from any systemic conditions and no previous drug affect bone metabolism.
Key exclusion criteria (6 listed)
- Smoking
- Pregnant women
- Patients in variation in anatomical landmarks
- Patients with psychological problems
- Patients with bad oral hygiene
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 placement using Densah bursUsing only Densah burs | Procedure or surgery | Implant placement using Densah burs only |
| implantation using Densah burs with Laser biostimulationlaser was used combined with Densah burs during implantation | Procedure or surgery | Implant placement using Densah burs combined with Laser biostimulation |
Primary outcome
immediate primary implant stability
Time frame: immediately
Immediate primary implant stability was assessed through the measurement of insertion torque. The unit of measurement is (N.cm)
4 secondary outcomes
Implant stability and ossification
Time frame: 6 months follow up
Modified Plaque Index
Time frame: after 12 months following up.
Probing depth
Time frame: after 12 months following up.
Modified gingival index
Time frame: after 12 months following up.
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 16 Apr 2026.
- Individual participant dataSharing planned: Yes. results telling which group has better healing and stability
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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.
Etimad Ah shoreibah, professor study chair
prof. of oral medicine, periodontology, Diagnosis and radiology
lobna mo abdelaziz, lecturer study director
lacturer of oral medicine, perio, diagnosis and radiology
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 placement using Densah burs and implantation using Densah burs with Laser biostimulation in people with Implant Stability and Osseointegration and Laser Effect Around Dental Implant, run by Faculty of Dental Medicine for Girls 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 3 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 16 Apr 2026. 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?
immediate primary implant stability (time frame: immediately). 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 16 Apr 2026.