Ridge SplittingNCT05837078
Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture
A study testing ridge splitting with implant placement in people with Ridge Splitting, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Splitting
- What is being tested?
- ridge splitting with implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2019to 19 Oct 2022
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- eligible patients must have mandibular knife edge ridge
Who cannot join
- contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser Bio-stimulation on Peri-implant Tissue Health for Mandibular Knife-edge Ridges Managed With One- Stage Ridge Splitting and Two- Implant Mandibular PEEK Overdentures. A One -Year Randomized Controlled Trial
This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.
Read the detailed description
This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.
- Conditions
- Ridge Splitting
- Being tested
- ridge splitting with implant placement
- Keywords
- peek , laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridge splitting with implant placementProcedure or surgery
ridge splitting of mandibular denture followed by two implant placement
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | patients had ridge splitting without laser bio stimulation and received two implants supported peek overdenture Receives: Procedure: ridge splitting with implant placement |
| study group | Active comparator | patients had ridge splitting with laser bio stimulation and received two implants supported peek overdenture Receives: Procedure: ridge splitting with implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone loss
measuring marginal bone loss arround dental implants in mm by digital radiograph
Measured: one year
plaque index
score 0 = no plaque; score1 = plaque only detected with a probe; score 2 = plaque visible to the naked eye; score 3 = abundant plaque1111
Measured: One year
bleeding index
score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding).
Measured: one year
gingival index
Score 0: normal peri implant mucosa; score 1: mild inflammation, slight colour change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.
Measured: one year
probing depth
A periodontal probe was used to measure pocket depth (PD). The distance between the marginal border of the mucosa and the tip of the periodontal probe at the base of the gingival sulcus was scored as the probing depth.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start20 Apr 2019
- Primary completion13 Jan 2021
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge SplittingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa adel, Mansoura University
- Investigators
- marwa adel, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837078
- Sponsor's protocol ID
- A01100918
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Bio-stimulation on Peri-implant Tissue Health for Mandibular Knife-edge Ridges Managed With One- Stage Ridge Splitting and Two- Implant Mandibular PEEK Overdentures. A One -Year Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05837078
- Acronym / sponsor ID
- A01100918
- Conditions
- Ridge Splitting
- Keywords
- peek , laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 1 May 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.
This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.
Detailed description
This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: ridge splitting with implant placementpatients had ridge splitting without laser bio stimulation and received two implants supported peek overdenture |
| study group | Active comparator | Procedure: ridge splitting with implant placementpatients had ridge splitting with laser bio stimulation and received two implants supported peek overdenture |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- eligible patients must have mandibular knife edge ridge
Key exclusion criteria (1 listed)
- contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus
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 |
|---|---|---|
| ridge splitting with implant placementridge splitting of mandibular denture followed by two implant placement | Procedure or surgery | control group, study group |
Primary outcome
crestal bone loss
Time frame: one year
measuring marginal bone loss arround dental implants in mm by digital radiograph
plaque index
Time frame: One year
score 0 = no plaque; score1 = plaque only detected with a probe; score 2 = plaque visible to the naked eye; score 3 = abundant plaque1111
bleeding index
Time frame: one year
score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding).
gingival index
Time frame: one year
Score 0: normal peri implant mucosa; score 1: mild inflammation, slight colour change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.
probing depth
Time frame: one year
A periodontal probe was used to measure pocket depth (PD). The distance between the marginal border of the mucosa and the tip of the periodontal probe at the base of the gingival sulcus was scored as the probing depth.
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 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Ridge Splitting
Active, not recruiting
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
Implant Stability
Recruiting
Outcomes of Ridge Splitting Versus Sausage Technique
Bone Loss, Alveolar
Not yet recruiting
Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge
Narrow Alveolar Ridge, CGF Concentrated Growth Factor
Not yet recruiting
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
Horizontal Bone Augmentation, Horizontal Ridge Deficiency
Recruiting
One Stage Ridge Splitting Using 2 Different Techniques in Maxilla
Ridge Augmentation, Bone Augmentation
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.
marwa adel, MD principal investigator
Mansoura 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 ridge splitting with implant placement in people with Ridge Splitting, run by Mansoura University 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 1 inclusion and 1 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 1 May 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?
crestal bone loss (time frame: one year). The study lists 5 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 1 May 2023.