Implant TherapyNCT06760442
Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement
A study testing Subcrestal implant placement and Crestal implant placement in people with Implant Therapy and Augmentation, Alveolar Ridge, run by Misr International University at 1 site in Egypt.
Trial summary
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Therapy, Augmentation, Alveolar Ridge
- What is being tested?
- Subcrestal implant placement and Crestal implant placement
- 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 Jan 2025to 1 Dec 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients older than 21 years.
- Patients having augmented (by 50/50 particulate xenograft and autogenous bone) edentulous posterior site with vertical bone height of > 10 mm in the mandible with a width of ridge ≥ 7 mm
- Adequate Inter-arch space for implant placement
- Favorable occlusion (no traumatic occlusion).
- Good oral hygiene.•Accepts 18 months follow-up period (cooperative patient)
- The patient provides informed consent.
Who cannot join
- Patients with inadequate bone volume and/ or quality
- Patients with remaining roots or with signs of acute infection related to the area of interest.
- Patients having systemic conditions that interfere with normal wound healing
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits .
- Smoker patients.
- Pregnant women.
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
Misr International University
Cairo
hani el Nahs professor, professor, 01221334637, hani.elnahas@dentistry.cu.edu.eg
Suzy nabil Phd, Phd, 01224785645, suzy.naiem@dentistry.cu.edu.eg
About this study
Official title: Radiographic Evaluation of Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement in Mandibular Posterior Augmented Ridge. A Randomized Controlled Clinical Trial.
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement
Read the detailed description
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement.
Materials and methods: This prospective, parallel, randomized controlled clinical trial will have 36 participants who need implant placement at the posterior mandibular area where they previously received horizontal bone augmentation. They will be randomly allocated into 2 groups, where group A (test) will receive dental implant placed subcrestally and group B (control) will receive implant placed equicrestally. Crestal bone loss will be assessed by periapical radiographs at implant placement (T0), 3 months (T3), 6 months (T6), 12 months (T12) and 18 months (T18) following implant placement. Keratinized tissue width, and soft tissue thickness will be measured clinically by periodontal probe at the same time points. Buccal bone changes will be evaluated at 18 months compared with the preoperative cone beam computed tomography by fusion module. Patient satisfaction will be recorded at the end of the trial.
- Conditions
- Implant Therapy, Augmentation, Alveolar Ridge
- Being tested
- Subcrestal implant placement, Crestal implant placement
- Keywords
- crestal bone level changes, subcrestal implant position, crestal implant position, augmented ridge, dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcrestal implant placementProcedure or surgery
Delayed implant placement 2 mm subcrestally in missing mandibular posterior site.
Crestal implant placementProcedure or surgery
Delayed implant placement equicrestally in missing mandibular posterior site.
| Study group | Role | What they receive |
|---|---|---|
| Subcrestal implant placement | Active comparator | Delayed implant placement 2 mm subcrestally in missing mandibular posterior site. Receives: Procedure: Subcrestal implant placement |
| Crestal implant placement | Active comparator | Delayed implant placement equicrestally in missing mandibular posterior site. Receives: Procedure: Crestal implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone changes
Periapical digital radiographs to determine the amount of crestal bone lose in mm
Measured: at baseline,3, 6 ,12 and 18 months
Secondary outcomes (2)
Keratinized tissue width
Keratinized tissue width using periodontal probe in mm
Measured: at baseline, 3,6,12 and 18 months
Patient satisfaction
Questionnaire
Measured: at baseline, 6 ,12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant TherapyStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hani el nahas professor, Professor, Study chair, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760442
- Sponsor's protocol ID
- Crestal Bone Changes
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement in Mandibular Posterior Augmented Ridge. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06760442
- Acronym / sponsor ID
- Crestal Bone Changes
- Conditions
- Implant Therapy, Augmentation, Alveolar Ridge
- Keywords
- crestal bone level changes, subcrestal implant position, crestal implant position, augmented ridge, dental implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Jan 2025 (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.
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement
Detailed description
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement.
Materials and methods: This prospective, parallel, randomized controlled clinical trial will have 36 participants who need implant placement at the posterior mandibular area where they previously received horizontal bone augmentation. They will be randomly allocated into 2 groups, where group A (test) will receive dental implant placed subcrestally and group B (control) will receive implant placed equicrestally. Crestal bone loss will be assessed by periapical radiographs at implant placement (T0), 3 months (T3), 6 months (T6), 12 months (T12) and 18 months (T18) following implant placement. Keratinized tissue width, and soft tissue thickness will be measured clinically by periodontal probe at the same time points. Buccal bone changes will be evaluated at 18 months compared with the preoperative cone beam computed tomography by fusion module. Patient satisfaction will be recorded at the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcrestal implant placement | Active comparator | Procedure: Subcrestal implant placementDelayed implant placement 2 mm subcrestally in missing mandibular posterior site. |
| Crestal implant placement | Active comparator | Procedure: Crestal implant placementDelayed implant placement equicrestally in missing mandibular posterior site. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients older than 21 years.
- Patients having augmented (by 50/50 particulate xenograft and autogenous bone) edentulous posterior site with vertical bone height of > 10 mm in the mandible with a width of ridge ≥ 7 mm
- Good oral hygiene.•Accepts 18 months follow-up period (cooperative patient)
- The patient provides informed consent.
Key exclusion criteria (6 listed)
- Patients with inadequate bone volume and/ or quality
- Patients with remaining roots or with signs of acute infection related to the area of interest.
- Patients having systemic conditions that interfere with normal wound healing
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits .
- 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 |
|---|---|---|
| Subcrestal implant placementDelayed implant placement 2 mm subcrestally in missing mandibular posterior site. | Procedure or surgery | Subcrestal implant placement |
| Crestal implant placementDelayed implant placement equicrestally in missing mandibular posterior site. | Procedure or surgery | Crestal implant placement |
Primary outcome
Crestal bone changes
Time frame: at baseline,3, 6 ,12 and 18 months
Periapical digital radiographs to determine the amount of crestal bone lose in mm
2 secondary outcomes
Keratinized tissue width
Time frame: at baseline, 3,6,12 and 18 months
Patient satisfaction
Time frame: at baseline, 6 ,12 and 18 months
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 16 Jul 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.
hani el nahas professor, Professor study chair
Misr International 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 Subcrestal implant placement and Crestal implant placement in people with Implant Therapy and Augmentation, Alveolar Ridge, run by Misr International 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 6 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 16 Jul 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 Hani El Nahas Professor, Professor (01221334637, hani.elnahass@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone changes (time frame: at baseline,3, 6 ,12 and 18 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 16 Jul 2026.