NCT06999915 The Effect of IPD on Lateral Bone Augmentation
| NCT ID | NCT06999915 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Guided Bone Regeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-06-24 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2026-06-24 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction. There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.
Eligibility Criteria
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.
Contact & Investigator
Nikos Mardas, DDS, MS, PhD
PRINCIPAL INVESTIGATOR
QMUL
Frequently Asked Questions
Who can join the NCT06999915 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Guided Bone Regeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06999915 currently recruiting?
Yes, NCT06999915 is actively recruiting participants. Contact the research team at BHNT.Clinicaloralresearchcentre@nhs.net for enrollment information.
Where is the NCT06999915 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06999915 clinical trial?
NCT06999915 is sponsored by Queen Mary University of London. The principal investigator is Nikos Mardas, DDS, MS, PhD at QMUL. The trial plans to enroll 28 participants.