Long-Term Bone Dimensional Changes Following Flapless Immediate Implant Placement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-54
SponsorInternational Dental Contiuing Education

About this trial

Nowadays, achieving long-term hard tissue stability is the definitive goal of a successful immediate implant placement and has become the optimal challenge for clinicians over the past few decades. It is wellestablished that the dimensional changes and remodeling of the alveolar ridge represent a physiologic sequela of tooth extraction and is inevitable especially the labial bone wall. This creates an unfavorable labio-palatal discrepancy and produces the "fixture-socket gap" around the coronal portion of the implant, known as the labial gap especially in sockets with thin bone.Although this gap has the potential to repair spontaneously in some cases, still previous studies reported that this gap cannot be completely filled without using a regenerative material. It has been claimed that buccal/labial gap augmentation contributes to the final esthetic success of the dental implant, where the regenerative material acts as a scaffold to maintain the blood clot, promote bone formation, compensate for the postextraction socket remodeling and maintain the buccal bone thickness and thereby preventing the buccal contour collapse. Nevertheless, this would add an additional cost and prolong the surgical procedure. Meanwhile, there is a controversy in the existing literature regarding the actual benefit of using bone grafts in the buccal gap. Previous systematic reviews concluded that there is not sufficient evidence to prove that immediate implant placement with grafting the labial gap, would comprise an additional benefit in preventing alveolar ridge reduction and contour collapse. Furthermore, previous controlled clinical trials reported that evidence for this additional treatment is still unclear.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (>20 years) with nonrestorable maxillary teeth in the esthetic zone, thick gingival phenotype, intact but thin labial plate of bone extending 7 mm (≤1 mm) and intact palatal bone extending at least 6 mm apically, sufficient apical bone to attain implant primary stability (a minimum of 35 N cm insertion torque) and labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5 mm.

Disqualifiers

Smokers, pregnant women, patients with systemic disease, patients with parafunctional habits such as bruxism or clenching, infected socket, periapical pathosis and history of radiotherapy or chemotherapy within the past 2 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IIP+Bone graft + CHA

    Procedure/Surgery

    A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging 3-4 mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading. The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm. Following implant placement, randomization sequence with allocation to either graft or no graft group was revealed. For patients assigned to receive a graft, demineralized bovine bone graft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) was placed in the gap labial to the implant to the level of the implant platform.

  • IIP +CHA only

    Procedure/Surgery

    A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging 3-4 mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading. The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm. Following implant placement, randomization sequence with allocation to either graft or no graft group was revealed. For patients assigned to receive no graft an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the mimicking the shape of the socket at the marginal gingiva was screwed to the implant

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: IIP + Bone graft + CHAActive comparator 1 intervention
Group B: IIP + CHA onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Labial bone formed labial to the implant

Measure using the CBCT, the amount of bone formed labial to the implant

Time frame
5 years follow up

Secondary outcomes

Other outcomes

Sponsors and contacts

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