Alveolar Bone LossNCT07608744
Alloplastic Graft vs Xenograft for Horizontal Alveolar Ridge Augmentation
A study testing Alloplastic bone graft and Xenograft in people with Alveolar Bone Loss and Edentulous Jaw, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This prospective split-mouth randomized controlled trial compared horizontal alveolar ridge augmentation using alloplastic bone graft versus xenograft, both performed simultaneously with implant placement using the decompression technique in the posterior mandible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Edentulous Jaw
- What is being tested?
- Alloplastic bone graft and Xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Oct 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral mandibular posterior edentulism with indication for implant-supported rehabilitation
- Sufficient vertical bone height but insufficient horizontal bone width for implant placement
- No infection at surgical site
- Non-smoker
- No head-and-neck radiotherapy within 2 years
- No uncontrolled systemic disease (controlled systemic conditions with INR <1.2 acceptable)
- Signed informed consent
Who cannot join
- No indication for implant-supported prosthesis
- Smoker
- Active infection at surgical site
- Head-and-neck radiotherapy within 2 years
- Uncontrolled systemic disease
- Allergy to study materials
Show all 12Show fewer
- Pregnancy
- Age under 18
- Medications interfering with surgical procedures
- History of mandibular fracture
- Contraindication to surgery determined by consultation
- Psychiatric disorder or inability to communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35040
About this study
Official title: Clinical and Radiological Evaluation Using Bone Graft Materials in Augmentation of Alveolar Bone Deficiency in Bilateral Posterior Mandible: A Randomized Controlled Study
This prospective split-mouth randomized controlled trial compared horizontal alveolar ridge augmentation using alloplastic bone graft versus xenograft, both performed simultaneously with implant placement using the decompression technique in the posterior mandible. Outcomes included postoperative edema, pain, soft tissue healing, and horizontal bone gain at 6 months assessed by CBCT.
- Conditions
- Alveolar Bone Loss, Edentulous Jaw
- Being tested
- Alloplastic bone graft, Xenograft
- Keywords
- atrophic mandible, bone augmentation, Decompression technique, alveolar ridge augmentation
- Medical subject headings
- Alveolar Bone Loss, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloplastic bone graftDevice
Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique
XenograftDevice
Xenograft with collagen membrane, simultaneous implant placement with decompression technique
| Study group | Role | What they receive |
|---|---|---|
| Alloplastic Bone Graft | Experimental | Alloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique Receives: Device: Alloplastic bone graft |
| Xenograft | Active comparator | Xenograft and collagen membrane, simultaneous implant placement with decompression technique Receives: Device: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Alveolar Bone Gain
Change in horizontal alveolar bone width measured by CBCT at baseline and 6 months
Measured: 6 months
Secondary outcomes (3)
Postoperative Edema
Facial edema assessed by measuring three surface distances (lateral orbital rim to mandibular angle, tragus to oral commissure, tragus to pogonion) at baseline, day 2, and day 7
Measured: 7 days
Postoperative Pain
Postoperative pain assessed using the Visual Analogue Scale (VAS); score range 0-10; higher scores indicate worse pain. VAS scores recorded daily for 7 days
Measured: 7 days
Soft Tissue Healing
Wound healing assessed using the Landry wound healing index; score range 1-5; higher scores indicate better healing. Landry wound healing index assessed at postoperative days 2 and 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Oct 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Ege 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
- Responsible party
- Principal investigator, Selin Kenç, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608744
- Sponsor's protocol ID
- EGE-OMFS-2019-144
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation Using Bone Graft Materials in Augmentation of Alveolar Bone Deficiency in Bilateral Posterior Mandible: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07608744
- Acronym / sponsor ID
- EGE-OMFS-2019-144
- Conditions
- Alveolar Bone Loss, Edentulous Jaw
- Keywords
- atrophic mandible, bone augmentation, Decompression technique, alveolar ridge augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 May 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.
This prospective split-mouth randomized controlled trial compared horizontal alveolar ridge augmentation using alloplastic bone graft versus xenograft, both performed simultaneously with implant placement using the decompression technique in the posterior mandible. Outcomes included postoperative edema, pain, soft tissue healing, and horizontal bone gain at 6 months assessed by CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alloplastic Bone Graft | Experimental | Device: Alloplastic bone graftAlloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique |
| Xenograft | Active comparator | Device: XenograftXenograft and collagen membrane, simultaneous implant placement with decompression technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Bilateral mandibular posterior edentulism with indication for implant-supported rehabilitation
- Sufficient vertical bone height but insufficient horizontal bone width for implant placement
- No infection at surgical site
- Non-smoker
- No head-and-neck radiotherapy within 2 years
Key exclusion criteria (12 listed)
- No indication for implant-supported prosthesis
- Smoker
- Active infection at surgical site
- Head-and-neck radiotherapy within 2 years
- Uncontrolled systemic disease
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 |
|---|---|---|
| Alloplastic bone graftAlloplastic bone graft with collagen membrane, simultaneous implant placement with decompression technique | Device | Alloplastic Bone Graft |
| XenograftXenograft with collagen membrane, simultaneous implant placement with decompression technique | Device | Xenograft |
Primary outcome
Horizontal Alveolar Bone Gain
Time frame: 6 months
Change in horizontal alveolar bone width measured by CBCT at baseline and 6 months
3 secondary outcomes
Postoperative Edema
Time frame: 7 days
Postoperative Pain
Time frame: 7 days
Soft Tissue Healing
Time frame: 7 days
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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 Alloplastic bone graft and Xenograft in people with Alveolar Bone Loss and Edentulous Jaw, run by Ege University at 1 site in Turkey (Türkiye).
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 7 inclusion and 12 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 3 Jun 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 Turkey (Türkiye). 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?
Horizontal Alveolar Bone Gain (time frame: 6 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 3 Jun 2026.