Dental bone graft study tests if 'Natural Shape' beats 'Extra Bulk' for implant success
NCT ID NCT06999915
First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 3 times
Summary
This study looks at whether adding bone graft up to a person's natural bone line (IPD) or slightly beyond it leads to better long-term stability after dental implant surgery. Twenty-eight adults needing a tooth replacement in the upper jaw will receive an implant and bone graft, with half getting a standard graft and half getting a slightly larger one. Over a year, the researchers will track bone changes, gum health, and patient satisfaction using CT scans and exams.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bovine bone mineral graft (Bio-Oss collagen) and bone level implant
- What this could lead to
- If successful, this could help dentists choose the best bone-grafting approach for more predictable and stable dental implant outcomes.
- What could go wrong
- This is a small, early-stage study with only 28 participants, so results may not apply to everyone. The extra bone graft may not improve stability and could cause complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult (\>18 years old) patients * Good medical and psychological health * Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment * Need of a tooth/teeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis * A relatively symmetrical maxillary arch * A nearly intact contra-lateral alveolar ridge * At least one neighbouring natural tooth present with healthy periodontal conditions * After implant placement, presence of a buccal bone dehiscence/ fenestration or buccal bone plate thickness of ≤ 1.5 mm requiring GBR (Monje et al., 2022; Jensen et al.,2023, Group 1 ITI Consensus Report). * At least 4 weeks of post-extraction socket healing and no ridge preservation prior to implant placement. * No acute infection at the site; adequate availability of bone apical and palatal to obtain implant primary stability * A functional occlusion with a minimum of 4 occlusal units (i.e., pairs of occluding posterior teeth) * Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered. Exclusion Criteria: * Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II). * Self-reported HIV or other severe immunosuppression. * Self-reported alcoholism or chronic drug abuse. * Heavy smokers ( \> 10 cigarettes/day) * Patients reporting use of vape/e-cigarettes * Self-reported pregnancy or lactation * Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit. * Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count. * Untreated caries lesions in neighbouring teeth and untreated/uncontrolled periodontal disease; If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment; * Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement. * Patients requiring maxillary sinus lift surgery before implant placement or presenting bone dimensions (at any time point of the study) that do not allow implant placement or there is no clinical indication to perform study procedures (i.e. bone augmentation, implant placement). * Patients not willing to receive animal-derived biomaterials for GBR. * Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Barts Health NHS Trust Dental Hospital
London, E1 1BB, United Kingdom
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Other studies related to the condition(s) this trial covers.
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