Atrophic RidgeNCT06176417
Comparison Between Different Horizontal Ridge Augmentation Techniques
A study testing horizontal ridge augmentation by decompression technique. and horizontal ridge augmentation by ridge splitting technique using piezosurgery. in people with Atrophic Ridge, run by Mansoura University at 1 site in Egypt.
Trial summary
Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth / teeth in posterior atrophic mandible by dental implant. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Ridge
- What is being tested?
- horizontal ridge augmentation by decompression technique. and horizontal ridge augmentation by ridge splitting technique using piezosurgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2021to 26 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's cooperation, motivation and good oral hygiene.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Moderately atrophic posterior mandible (horizontal alveolar dimension is not more than 4 mm at the crest), with minimum 10 mm vertical height.
- Patients prepared to comply with the follow-up and maintenance programme.
- Free from history of bruxism / parafunctional habits.
Who cannot join
- Patients with local pathological disease such as cyst, tumor at the planned surgical site.
- Pregnant patients.
- Heavy smoker patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Horizontal Ridge Augmentation Using Decompression Technique Versus Ridge Splitting in Atrophic Posterior Mandibular Ridge With Simultaneous Implant Placement
Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth / teeth in posterior atrophic mandible by dental implant.
Patients' grouping:
Read more
Patients were divided randomly into two equal uniform groups as follow:
Group I:
Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique.
Group II:
Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery.
All patients were evaluated clinically and radiographically at regular time interval immediately, 6 and 12 months after surgery.
- Conditions
- Atrophic Ridge
- Being tested
- horizontal ridge augmentation by decompression technique., horizontal ridge augmentation by ridge splitting technique using piezosurgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
horizontal ridge augmentation by decompression technique.Procedure or surgery
Instead of a cover screw, a 2-mm healing abutment was used after implant insertion
horizontal ridge augmentation by ridge splitting technique using piezosurgery.Procedure or surgery
horizontal ridge augmentation was done using piezosurgery tips and bone expanders
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique. Receives: Procedure: horizontal ridge augmentation by decompression technique. |
| group 2 | Experimental | Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery. Receives: Procedure: horizontal ridge augmentation by ridge splitting technique using piezosurgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge width
The ridge width was measured on the cross section view at different time interval from the outer surface of the buccal bone to the outer surface of the lingual bone perpendicular to the line marking the long axis of the implant at implant platform.
Changes in alveolar ridge width was measured by subtracting ridge width value after 6 and 12 months from immediate postoperative.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start26 Aug 2021
- Primary completion26 Aug 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic RidgeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara elmaghraby, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176417
- Sponsor's protocol ID
- A03030821
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation Using Decompression Technique Versus Ridge Splitting in Atrophic Posterior Mandibular Ridge With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06176417
- Acronym / sponsor ID
- A03030821
- Conditions
- Atrophic Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 19 Dec 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.
Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth / teeth in posterior atrophic mandible by dental implant.
Patients' grouping:
Patients were divided randomly into two equal uniform groups as follow:
Group I:
Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique.
Group II:
Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery.
All patients were evaluated clinically and radiographically at regular time interval immediately, 6 and 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Procedure: horizontal ridge augmentation by decompression technique.Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique. |
| group 2 | Experimental | Procedure: horizontal ridge augmentation by ridge splitting technique using piezosurgery.Eight implants were placed in patients of missing single tooth / teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient's cooperation, motivation and good oral hygiene.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Moderately atrophic posterior mandible (horizontal alveolar dimension is not more than 4 mm at the crest), with minimum 10 mm vertical height.
- Patients prepared to comply with the follow-up and maintenance programme.
- Free from history of bruxism / parafunctional habits.
Key exclusion criteria (3 listed)
- Patients with local pathological disease such as cyst, tumor at the planned surgical site.
- Pregnant patients.
- Heavy smoker patients.
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 |
|---|---|---|
| horizontal ridge augmentation by decompression technique.Instead of a cover screw, a 2-mm healing abutment was used after implant insertion | Procedure or surgery | group 1 |
| horizontal ridge augmentation by ridge splitting technique using piezosurgery.horizontal ridge augmentation was done using piezosurgery tips and bone expanders | Procedure or surgery | group 2 |
Primary outcome
Alveolar ridge width
Time frame: 12 months
The ridge width was measured on the cross section view at different time interval from the outer surface of the buccal bone to the outer surface of the lingual bone perpendicular to the line marking the long axis of the implant at implant platform. Changes in alveolar ridge width was measured by subtracting ridge width value after 6 and 12 months from immediate postoperative.
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 19 Dec 2023.
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Ridge 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.
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 horizontal ridge augmentation by decompression technique. and horizontal ridge augmentation by ridge splitting technique using piezosurgery. in people with Atrophic Ridge, 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 5 inclusion and 3 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 19 Dec 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?
Alveolar ridge width (time frame: 12 months). 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 19 Dec 2023.