Dental Implant StabilityNCT06148064
EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET
A study testing Collaplug with low level laser and Collaplug in people with Dental Implant Stability, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Implant Stability
- What is being tested?
- Collaplug with low level laser and Collaplug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2022to 8 Aug 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
- Type I post-extraction sockets with all bony walls intact.
- No signs of active periodontal disease in the selected tooth.
Who cannot join
- The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
- The presence of acute periapical infection.
- The presence of any local factor that may interfere with extraction as tooth ankyloses.
- Subjects who had undergone therapeutical radiation.
- Patients who had been subjected to or who were under bisphosphonate therapy
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.
- Conditions
- Dental Implant Stability
- Being tested
- Collaplug with low level laser, Collaplug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaplug with low level laserOther
Immediate implant placement with applying a collaplug material in the jumping gap followed by low level laser application using Siro laser (660 nm, avg. power density: 0.5-WATT) circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing.
CollaplugOther
Implant of suitable diameter and height was placed in the fresh extracted socket immediately after extraction and the jumping gap was augmented by the collaplug followed by healing abutment placement.
| Study group | Role | What they receive |
|---|---|---|
| Collaplug application with low level laser application. | Experimental | Not described Receives: Other: Collaplug with low level laser |
| Collaplug application | Active comparator | Not described Receives: Other: Collaplug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability was measured by OSSTELL at 4 different levels (buccal, lingual, mesial, and distal). Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. Higher levels indicate greater stability.
Measured: up to 3 months
Crestal bone loss
Crestal bone loss was assessed using cone beam computed tomography (CBCT) by measuring the distance from the bone crest to the implant apex from mesial, distal, lingual and buccal aspects intraoperatively. Crestal bone loss up to 1.5 mm is considered a normal early finding through the first year after implant placement.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start7 Sep 2022
- Primary completion1 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant StabilityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Nermine A Elnakib, BDS, Principal investigator, Alexandria UniversityMaha R Talaab, PhD, Study chair, Alexandria UniversityNayrouz A Metwally, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148064
- Sponsor's protocol ID
- #2/3/2023
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET
- ClinicalTrials.gov ID
- NCT06148064
- Acronym / sponsor ID
- #2/3/2023
- Conditions
- Dental Implant Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 28 Nov 2023 (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.
Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaplug application with low level laser application. | Experimental | Other: Collaplug with low level laser |
| Collaplug application | Active comparator | Other: Collaplug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
- Type I post-extraction sockets with all bony walls intact.
- No signs of active periodontal disease in the selected tooth.
Key exclusion criteria (5 listed)
- The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
- The presence of acute periapical infection.
- The presence of any local factor that may interfere with extraction as tooth ankyloses.
- Subjects who had undergone therapeutical radiation.
- Patients who had been subjected to or who were under bisphosphonate therapy
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 |
|---|---|---|
| Collaplug with low level laserImmediate implant placement with applying a collaplug material in the jumping gap followed by low level laser application using Siro laser (660 nm, avg. power density: 0.5-WATT) circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing. | Other | Collaplug application with low level laser application. |
| CollaplugImplant of suitable diameter and height was placed in the fresh extracted socket immediately after extraction and the jumping gap was augmented by the collaplug followed by healing abutment placement. | Other | Collaplug application |
Primary outcome
Implant stability
Time frame: up to 3 months
Implant stability was measured by OSSTELL at 4 different levels (buccal, lingual, mesial, and distal). Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. Higher levels indicate greater stability.
Crestal bone loss
Time frame: up to 3 months
Crestal bone loss was assessed using cone beam computed tomography (CBCT) by measuring the distance from the bone crest to the implant apex from mesial, distal, lingual and buccal aspects intraoperatively. Crestal bone loss up to 1.5 mm is considered a normal early finding through the first year after implant placement.
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 28 Nov 2023.
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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.
Nermine A Elnakib, BDS principal investigator
Alexandria University
Maha R Talaab, PhD study chair
Alexandria University
Nayrouz A Metwally, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaplug with low level laser and Collaplug in people with Dental Implant Stability, run by Nourhan M.Aly 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 5 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 28 Nov 2023. 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?
Implant stability (time frame: up to 3 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 28 Nov 2023.