Vertical Implant PositionNCT07483086
Influence of Vertical Implant Position on Marginal Bone Loss in Cases With Thin Phenotype
A study testing Delayed implant with immediate temporization placed 2 mm subcrestal level and Delayed implant with immediate temporization placed at the crestal level in people with Vertical Implant Position and Delayed Implant Placement With Immediate Loading, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertical Implant Position, Delayed Implant Placement With Immediate Loading, Tooth Loss / Rehabilitation
- What is being tested?
- Delayed implant with immediate temporization placed 2 mm subcrestal level and Delayed implant with immediate temporization placed at the crestal level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2025to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with single missing upper anterior or premolar teeth
- Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6 mm
- Patients with thin soft tissue phenotype
- Patients with healthy systemic conditions.
- Patients older than 18 years.
- Good oral hygiene.
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- Cooperative patients who accept a one-year follow-up period.
- Patients who consent to being part of the study (sign an informed consent form).
- Adequate inter-arch space for implant placement.
- Favorable occlusion (no traumatic occlusion).
- Absence of allergy to the prescribed medications.
Who cannot join
- Patients with inadequate bone volume and/ or quality
- Patients with local root remnants
- Patients with inadequate wound healing
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- Heavy smokers (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
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- Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
- Pregnant or nursing women.
- Uncooperative patients.
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
Tala H Elbanna, 00201017770662, tala.abdelfattah@dentistry.cu.edu.eg
About this study
Official title: The Influence of Vertical Implant Position With Immediate Temporization on Marginal Bone Loss in Cases With Thin Soft Tissue Phenotype: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. The main questions it aims to answer are:
Does vertical implant position below the crest of the bone lead to less marginal bone loss? Will it affect implant survival as well as quality of soft tissue, esthetics and patient satisfaction?
Participants will:
Have an implant placed at the bone level or 2 mm below the bone level Visit the clinic once every 3 months for checkups, radiographs, and readings
Read the detailed description
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics (Degidi et al., 2011).
With respect to the depth of insertion, implants can be placed at various levels in the bone, which affects the peri-implant tissues with the surrounding marginal bone. Therefore, placement of an implant in a deeper position with respect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to maintain the peri-implant soft and hard tissues in comparison with crestal placement, though this affirmation is subject to controversy (Pellicer-Chover et al., 2019).
Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Each patient will be examined to confirm meeting the eligibility criteria. A full medical and dental history will be taken, and proper oral examination will be performed. Then a pre-operative cone beam computed tomography (CBCT) will be taken to examine both the bucco-lingual bone dimension and bone height and to ensure that the area of interest is free of any pathological lesions.
All the steps will be explained in detail to each patient and an informed consent will be taken from the patient to agree on their enrolment in the clinical trial. Then the patient will be treated first by phase I therapy for periodontal treatment through conventional supragingival scaling and subgingival debridement. Then strict oral hygiene instructions will be given and patients will be reassessed after a period of 4 weeks. Reassessment of the case is to ensure absence of any signs of inflammation and presence of normal tissues before the surgical procedure.
Clinical photographs will be taken at baseline, during surgery and at 3, 6 and 12 months postoperatively.
The patients will be randomly assigned into two groups:
Intervention group: Patients receiving delayed implant placed 2 mm subcrestal with immediate temporization
Control group: Patients receiving delayed implant placed equicrestal with immediate temporization
Surgical procedure:
- Topical anesthesia will be administered using infiltration technique in the labial and palatal sides of the area of interest.
- Full-thickness midcrestal incision to expose the bone.
- Implant insertion will be performed according to the manufacturer's instructions; drills will be used sequentially until the required implant diameter is reached with insertion of the paralleling pin in the osteotomy site to evaluate the proper position in bucco-lingual and mesio-distal direction
- Then the implant will be placed Intervention group: inserted 2 mm apical to the alveolar bone crest with adequate primary stability. Control group: inserted at the same level of the alveolar bone crest with adequate primary stability.
- After implant insertion, a healing collar will be placed over the implant. Then the flap will be repositioned and sutured.
- After suturing, the healing collar will be removed and a scan body will be inserted for digital impression and immediate temporary PMMA crown will be delivered over a temporary abutment for both groups.
Postoperative Care:
Postoperative medication:
Administration of:
- Antiseptic mouth rinse with Chlorhexidine (0.12%) two times a day for 1 week.
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 400 mg three times daily for 3 days).
- Antibiotic (Hibiotic 1gm) will be prescribed for the patient twice daily for one week.
Patient self-care instructions:
Post-operative instructions:
- Each patient will be instructed to apply cold fomentation for the first 6 hours.
- Avoid tooth-brushing at the surgical site for the first 14 days and proper rinsing after every meal starting from the second day.
- Hot beverages will not be permitted for the first 24 hours.
- Each patient will be instructed to rinse with Chlorohexidine mouthwash every 12 hours for 14 days.
- The patient will be asked to contact the operator for any unexpected complications.
- The sutures will be removed 10 days post-operative.
Follow-up:
Each patient will be evaluated at 3, 6, 9 and 12 months post-operatively.
- Conditions
- Vertical Implant Position, Delayed Implant Placement With Immediate Loading, Tooth Loss / Rehabilitation
- Being tested
- Delayed implant with immediate temporization placed 2 mm subcrestal level, Delayed implant with immediate temporization placed at the crestal level
- Keywords
- Vertical position, subcrestal, crestal, delayed implant placement with immediate loading, vertical dental implant position
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed implant with immediate temporization placed 2 mm subcrestal levelProcedure or surgery
2 mm subcrestal placement
Delayed implant with immediate temporization placed at the crestal levelProcedure or surgery
crestal level placement
| Study group | Role | What they receive |
|---|---|---|
| Delayed implant with immediate temporization placed 2 mm subcrestal level | Experimental | Not described Receives: Procedure: Delayed implant with immediate temporization placed 2 mm subcrestal level |
| Delayed implant with immediate temporization placed at crestal bone level | Active comparator | Not described Receives: Procedure: Delayed implant with immediate temporization placed at the crestal level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss (crestal bone loss)
measured linearly in mm by comparing periapical radiographs
Measured: Assessment at baseline, 3 months post-operative, 6 months post-operative, 9 months post-operative and 12 months post-operative
Secondary outcomes (8)
Midfacial recession
Corono-apical distance measured from the incisal edge/cusp tip to the peri-implant soft tissue margin
Measured: 0, 3, 6, 9, 12 months post-operative
Pink Esthetic Score (PES)
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and soft tissue texture, all using a 0-1-2 scoring system, 0 being the lowest and 2 the highest value. The maximum achievable PES is 14.
Measured: baseline, 3, 6, 9, 12 months post-operative
Gingival thickness
Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until the needle contacts bone, at 3 different points. Three readings will be taken mid-buccally at three different levels; 2 mm, 4 mm and 6 mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a caliper.
Measured: baseline, 3, 6, 9, 12 months post-operative
Implant survival
A binary outcome, the definition of implant success was based on the clinical and radiographic criteria described by Buser et al. 1990; 1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading (Buser, Weber and Lang, 1990)
Measured: 12 months post-operative
Post-operative patient satisfaction
A 12-item questionnaire is self-reported by the patients after 12 months post-operative; six questions with scores from 1 to 10 with the poorest score (not very satisfied) being 0 and the optimum score (satisfied) 10. The other six questions are yes or no questions (Derks et al., 2014)
Measured: 12 months post-operative
Radiographic horizontal bucco-palatal bone changes
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the three measurements will be at three levels: the implant platform, 2 mm and 5 mm from the platform. (Koerich et al., 2016).
Measured: baseline, 12 months post-operative
Radiographic vertical bone changes
Vertical bone height will be measured. Measurement will be taken at the highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. The difference between pre- and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension (Wu et al. 2019).
Measured: baseline, 12 months post-operative
Emergence angle
The angle between the tangent line of the restoration at the most coronal point of the buccal mucosa and the implant long axis (Wang et al., 2022).
Measured: baseline, 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 Mar 2026
- Study start16 Jan 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Implant PositionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tala Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483086
- Sponsor's protocol ID
- PER 00-6-3-2
- Other IDs
- 4511906268
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vertical Implant Position With Immediate Temporization on Marginal Bone Loss in Cases With Thin Soft Tissue Phenotype: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07483086
- Acronym / sponsor ID
- PER 00-6-3-2
- Conditions
- Vertical Implant Position, Delayed Implant Placement With Immediate Loading, Tooth Loss / Rehabilitation
- Keywords
- Vertical position, subcrestal, crestal, delayed implant placement with immediate loading, vertical dental implant position
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Mar 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.
The goal of this clinical trial is to learn if vertical position of the dental implant will affect the bone around the implant in place of a missing tooth that happens to be bounded by two natural teeth. It will also measure esthetics and patient satisfaction. The main questions it aims to answer are:
Does vertical implant position below the crest of the bone lead to less marginal bone loss? Will it affect implant survival as well as quality of soft tissue, esthetics and patient satisfaction?
Participants will:
Have an implant placed at the bone level or 2 mm below the bone level Visit the clinic once every 3 months for checkups, radiographs, and readings
Detailed description
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics (Degidi et al., 2011).
With respect to the depth of insertion, implants can be placed at various levels in the bone, which affects the peri-implant tissues with the surrounding marginal bone. Therefore, placement of an implant in a deeper position with respect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to maintain the peri-implant soft and hard tissues in comparison with crestal placement, though this affirmation is subject to controversy (Pellicer-Chover et al., 2019).
Study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University, Egypt.
Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Each patient will be examined to confirm meeting the eligibility criteria. A full medical and dental history will be taken, and proper oral examination will be performed. Then a pre-operative cone beam computed tomography (CBCT) will be taken to examine both the bucco-lingual bone dimension and bone height and to ensure that the area of interest is free of any pathological lesions.
All the steps will be explained in detail to each patient and an informed consent will be taken from the patient to agree on their enrolment in the clinical trial. Then the patient will be treated first by phase I therapy for periodontal treatment through conventional supragingival scaling and subgingival debridement. Then strict oral hygiene instructions will be given and patients will be reassessed after a period of 4 weeks. Reassessment of the case is to ensure absence of any signs of inflammation and presence of normal tissues before the surgical procedure.
Clinical photographs will be taken at baseline, during surgery and at 3, 6 and 12 months postoperatively.
The patients will be randomly assigned into two groups:
Intervention group: Patients receiving delayed implant placed 2 mm subcrestal with immediate temporization
Control group: Patients receiving delayed implant placed equicrestal with immediate temporization
Surgical procedure:
- Topical anesthesia will be administered using infiltration technique in the labial and palatal sides of the area of interest.
- Full-thickness midcrestal incision to expose the bone.
- Implant insertion will be performed according to the manufacturer's instructions; drills will be used sequentially until the required implant diameter is reached with insertion of the paralleling pin in the osteotomy site to evaluate the proper position in bucco-lingual and mesio-distal direction
- Then the implant will be placed Intervention group: inserted 2 mm apical to the alveolar bone crest with adequate primary stability. Control group: inserted at the same level of the alveolar bone crest with adequate primary stability.
- After implant insertion, a healing collar will be placed over the implant. Then the flap will be repositioned and sutured.
- After suturing, the healing collar will be removed and a scan body will be inserted for digital impression and immediate temporary PMMA crown will be delivered over a temporary abutment for both groups.
Postoperative Care:
Postoperative medication:
Administration of:
- Antiseptic mouth rinse with Chlorhexidine (0.12%) two times a day for 1 week.
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 400 mg three times daily for 3 days).
- Antibiotic (Hibiotic 1gm) will be prescribed for the patient twice daily for one week.
Patient self-care instructions:
Post-operative instructions:
- Each patient will be instructed to apply cold fomentation for the first 6 hours.
- Avoid tooth-brushing at the surgical site for the first 14 days and proper rinsing after every meal starting from the second day.
- Hot beverages will not be permitted for the first 24 hours.
- Each patient will be instructed to rinse with Chlorohexidine mouthwash every 12 hours for 14 days.
- The patient will be asked to contact the operator for any unexpected complications.
- The sutures will be removed 10 days post-operative.
Follow-up:
Each patient will be evaluated at 3, 6, 9 and 12 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed implant with immediate temporization placed 2 mm subcrestal level | Experimental | Procedure: Delayed implant with immediate temporization placed 2 mm subcrestal level |
| Delayed implant with immediate temporization placed at crestal bone level | Active comparator | Procedure: Delayed implant with immediate temporization placed at the crestal level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with single missing upper anterior or premolar teeth
- Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6 mm
- Patients with thin soft tissue phenotype
- Patients with healthy systemic conditions.
- Patients older than 18 years.
Key exclusion criteria (9 listed)
- Patients with inadequate bone volume and/ or quality
- Patients with local root remnants
- Patients with inadequate wound healing
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
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 |
|---|---|---|
| Delayed implant with immediate temporization placed 2 mm subcrestal level2 mm subcrestal placement | Procedure or surgery | Delayed implant with immediate temporization placed 2 mm subcrestal level |
| Delayed implant with immediate temporization placed at the crestal levelcrestal level placement | Procedure or surgery | Delayed implant with immediate temporization placed at crestal bone level |
Primary outcome
Marginal bone loss (crestal bone loss)
Time frame: Assessment at baseline, 3 months post-operative, 6 months post-operative, 9 months post-operative and 12 months post-operative
measured linearly in mm by comparing periapical radiographs
8 secondary outcomes
Midfacial recession
Time frame: 0, 3, 6, 9, 12 months post-operative
Pink Esthetic Score (PES)
Time frame: baseline, 3, 6, 9, 12 months post-operative
Gingival thickness
Time frame: baseline, 3, 6, 9, 12 months post-operative
Implant survival
Time frame: 12 months post-operative
Post-operative patient satisfaction
Time frame: 12 months post-operative
Radiographic horizontal bucco-palatal bone changes
Time frame: baseline, 12 months post-operative
Radiographic vertical bone changes
Time frame: baseline, 12 months post-operative
Emergence angle
Time frame: baseline, 12 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 2 Apr 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed implant with immediate temporization placed 2 mm subcrestal level and Delayed implant with immediate temporization placed at the crestal level in people with Vertical Implant Position and Delayed Implant Placement With Immediate Loading, 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 11 inclusion and 9 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 2 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (crestal bone loss) (time frame: Assessment at baseline, 3 months post-operative, 6 months post-operative, 9 months post-operative and 12 months post-operative). 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 2 Apr 2026.