Bone grafting beyond the original bone line for dental implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-center, prospective, non-inferiority trial comparing two lateral bone augmentation approaches used with guided bone regeneration for dental implants. Participants are adults needing an implant-supported prosthesis in the upper front region and with specific oral-health criteria. The study uses CBCT imaging over about 16 to 18 months to compare bone stability, soft tissue healing, gum blood flow, implant success, and patient satisfaction between contour augmentation up to the original bone line and over-contour augmentation about 3 mm beyond it. It aims to determine if extending the graft beyond IPD offers similar or better outcomes without compromising safety. The trial includes two parallel groups and follows standard protocols at Queen Mary University of London and the University of Belgrade.

Why it matters

Who can join: the full rules

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.

Where it's running

• Barts Health NHS Trust Dental Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Nikos Mardas, DDS, MS, PhD — Qmul
• Study coordinator: Miljana Bacevic, DDS, PhD
• Email: BHNT.Clinicaloralresearchcentre@nhs.net
• Phone: 02078828641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.