The Effect of IPD on Lateral Bone Augmentation

Launched by QUEEN MARY UNIVERSITY OF LONDON · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a technique called Guided Bone Regeneration (GBR), which is used during dental implant surgery to help rebuild bone around the implant. The researchers want to understand if the amount of bone that regrows depends on the natural shape of a person's bone, known as the Individual Phenotypical Dimension (IPD). They will compare two different methods: one that adds bone only up to the original bone shape and another that adds bone slightly beyond it. Over a year, the trial will look at how well the bone and gums heal, how successful the implants are, and how satisfied patients feel with their results.

To be eligible for the trial, participants need to be adults older than 18, in good health, and need a tooth replaced in the upper front or side of their mouth. They also must have specific dental conditions, such as certain levels of gum health and bone thickness. Participants can expect to receive either of the two bone grafting methods and will have regular scans to check the healing process. It's important to note that certain health conditions, like severe bone diseases or uncontrolled diabetes, will exclude individuals from participating. If you're interested, you'll need to read and sign a consent form to confirm your understanding of the study.

Gender

ALL

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.