Horizontal Atrophy of Edentulous Alveolar RidgeNCT06221306
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
A study testing Dental implant: NDI and Dental implant: SDI in people with Horizontal Atrophy of Edentulous Alveolar Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as guided bone regeneration, are often required to augment the deficient hard tissue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Horizontal Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Dental implant: NDI and Dental implant: SDI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients having mandibular edentulous posterior site requiring implant placement.
- Available vertical bone height of ≥ 8 mm in the mandible and ridge width 5-6 mm in width.
- Tooth extraction ≥3 months before surgical intervention.
- Patients without systemic diseases interfering with implant therapy.
- Patients aged ≥ 18 years old.
- Good oral hygiene.
Who cannot join
- Patients with systemic conditions known to affect bone metabolism and healing
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Greater Cairo, 12613
Hani El Nahass, Professor
About this study
Official title: Radiographic Evaluation of Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants in Conjunction With Bone Augmentation in Horizontally Deficient Posterior Mandibular Partially Edentulous Sites: A Randomized Clinical Trial
Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as guided bone regeneration, are often required to augment the deficient hard tissue. However, additional surgical procedures often add morbidity to the patient in addition to prolonging the treatment time and raising the treatment cost.
Hence, simpler, less invasive treatment options are preferred by patients. The use of narrow diameter implants (NDI) offers the great advantage of eliminating the need for augmentation procedures.
Read the detailed description
Various methods of additional surgical procedures have been introduced to overcome reduced bone volume situations, relevant to the site, size and nature of the defect such as: maxillary sinus floor lifting and augmentation, vertical and lateral ridge augmentation by means of autogenous or bone substitutes, particulate or blocks. Lateral bone augmentation performed simultaneously with implant placement has been a well-established treatment option for horizontal ridge deficiencies.
Such additional procedures are associated with longer surgical time, greater morbidity and greater risk to complications such as: pain, infection, nerve damage, bleeding, wound dehiscence or even graft or implant failure. In addition to, higher treatment cost and a longer healing time. Furthermore, an additional surgical procedure should be considered with caution in medically compromised patients. Moreover, surgical expertise of the operator is required for performing such procedures.
NDIs showed promising results with reported survival rates 95% - 100%. However, prosthetic complications such as: abutment fracture, loss of crown retention and screw loosening were reported.
The successful outcomes of NDI have supported widening the scope to include premolars and molars, particularly where averting an additional augmentation procedure is favoured.
However, areas of concern remain evident regarding; the impact of loading on a reduced surface for osseointegration, the increased probability of fracture, the probable prosthetic complications and the loading stresses affecting crestal bone resorption. In addition to oral health-related quality of life for the patients. Limited literature is found regarding the use of NDI to restore posterior mandibular edentulous sites.
Several studies have compared NDI to SDI in pristine bone. To our knowledge few RCTs compared NDIs to SDI with simultaneous lateral bone augmentation for the treatment of atrophic posterior mandibular ridges, none assessing both crestal bone resorption in addition to oral health related quality of life (OHRQoL) assessment.
- Being tested
- Dental implant: NDI, Dental implant: SDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant: NDIProcedure or surgery
Placement of narrow diameter implants (NDI) (3.3) in the dentoalveolar ridge
Dental implant: SDIProcedure or surgery
Placement of standard diameter implants (SDI) (4.1) in the dentoalveolar ridge with simaltenous bone augmentation
| Study group | Role | What they receive |
|---|---|---|
| Narrow diameter implant placement (NDI) (3.3) | Experimental | Not described Receives: Procedure: Dental implant: NDI |
| Standard diameter implant (SDI) placement (4.1) with simultaneous bone augmentation. | Active comparator | Not described Receives: Procedure: Dental implant: SDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of crestal bone changes
Linear measurements (in mm) for the crestal bone level changes on periapical digital radiographs
Measured: 1 year
Secondary outcomes (1)
Prosthetic complications
screw loosening, fracture of restoration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Atrophy of Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzy Nabil Naiem, Cairo University
- Investigators
- Manal Hosny, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221306
- Sponsor's protocol ID
- blt
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants in Conjunction With Bone Augmentation in Horizontally Deficient Posterior Mandibular Partially Edentulous Sites: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06221306
- Acronym / sponsor ID
- blt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Jan 2024 (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.
Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as guided bone regeneration, are often required to augment the deficient hard tissue. However, additional surgical procedures often add morbidity to the patient in addition to prolonging the treatment time and raising the treatment cost.
Hence, simpler, less invasive treatment options are preferred by patients. The use of narrow diameter implants (NDI) offers the great advantage of eliminating the need for augmentation procedures.
Detailed description
Various methods of additional surgical procedures have been introduced to overcome reduced bone volume situations, relevant to the site, size and nature of the defect such as: maxillary sinus floor lifting and augmentation, vertical and lateral ridge augmentation by means of autogenous or bone substitutes, particulate or blocks. Lateral bone augmentation performed simultaneously with implant placement has been a well-established treatment option for horizontal ridge deficiencies.
Such additional procedures are associated with longer surgical time, greater morbidity and greater risk to complications such as: pain, infection, nerve damage, bleeding, wound dehiscence or even graft or implant failure. In addition to, higher treatment cost and a longer healing time. Furthermore, an additional surgical procedure should be considered with caution in medically compromised patients. Moreover, surgical expertise of the operator is required for performing such procedures.
NDIs showed promising results with reported survival rates 95% - 100%. However, prosthetic complications such as: abutment fracture, loss of crown retention and screw loosening were reported.
The successful outcomes of NDI have supported widening the scope to include premolars and molars, particularly where averting an additional augmentation procedure is favoured.
However, areas of concern remain evident regarding; the impact of loading on a reduced surface for osseointegration, the increased probability of fracture, the probable prosthetic complications and the loading stresses affecting crestal bone resorption. In addition to oral health-related quality of life for the patients. Limited literature is found regarding the use of NDI to restore posterior mandibular edentulous sites.
Several studies have compared NDI to SDI in pristine bone. To our knowledge few RCTs compared NDIs to SDI with simultaneous lateral bone augmentation for the treatment of atrophic posterior mandibular ridges, none assessing both crestal bone resorption in addition to oral health related quality of life (OHRQoL) assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow diameter implant placement (NDI) (3.3) | Experimental | Procedure: Dental implant: NDI |
| Standard diameter implant (SDI) placement (4.1) with simultaneous bone augmentation. | Active comparator | Procedure: Dental implant: SDI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients having mandibular edentulous posterior site requiring implant placement.
- Available vertical bone height of ≥ 8 mm in the mandible and ridge width 5-6 mm in width.
- Tooth extraction ≥3 months before surgical intervention.
- Patients without systemic diseases interfering with implant therapy.
- Patients aged ≥ 18 years old.
Key exclusion criteria (2 listed)
- Patients with systemic conditions known to affect bone metabolism and healing
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
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 |
|---|---|---|
| Dental implant: NDIPlacement of narrow diameter implants (NDI) (3.3) in the dentoalveolar ridge | Procedure or surgery | Narrow diameter implant placement (NDI) (3.3) |
| Dental implant: SDIPlacement of standard diameter implants (SDI) (4.1) in the dentoalveolar ridge with simaltenous bone augmentation | Procedure or surgery | Standard diameter implant (SDI) placement (4.1) with simultaneous bone augmentation. |
Primary outcome
Amount of crestal bone changes
Time frame: 1 year
Linear measurements (in mm) for the crestal bone level changes on periapical digital radiographs
1 secondary outcome
Prosthetic complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
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.
Manal Hosny, Professor study director
Cairo 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 Dental implant: NDI and Dental implant: SDI in people with Horizontal Atrophy of Edentulous Alveolar Ridge, run by Cairo 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzy Naiem, MSc (+201224785645, suzy.naiem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of crestal bone changes (time frame: 1 year). 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 23 Jan 2026.