About this trial
This study aims to evaluate the effectiveness of the tent pole technique in vertical peri-implant soft tissue augmentation and to assess its impact on marginal bone loss. Additionally, the adjunctive use of platelet-rich fibrin and photobiomodulation will be explored to determine their influence on the clinical outcomes of this procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be over 18 years of age. They should be legally capable of adhering to study protocols, which include maintaining proper oral hygiene, attending all scheduled follow-up visits, fully understanding the proposed surgical procedures, and signing the informed consent form.
single edentulous sites in the premolar and/or molar region of the mandible.
Vertical gingival thickness must be more than 1 mm and less than or equal to 2 mm.
A minimum of 2 mm of attached gingiva should be present on both the buccal and lingual sides of the implant sites.
Disqualifiers
Presence of general contraindications for dental implants or surgical interventions.
Heavy smoking, defined as more than 10 cigarettes daily, including pipe, vape or cigar use.
Poor oral hygiene, characterized by probing depths greater than 4 mm in adjacent teeth, and a full mouth plaque score (FMPS) or full mouth bleeding score (FMBS) exceeding 25% after the pre-treatment phase.
Guided bone regeneration at the implant site.
Trial design
Factorial
Treatments tested in this trial
VST augmentation with TPT
Procedure/SurgeryFor TPT group, vertical soft tissue augmentation will be performed simultaneously with implant placement using a 2 mm healing abutment. Than, to ensure tension-free primary closure, mucoperiosteal flaps will be mobilized through vertical releasing incisions. Wound closure will be achieved using horizontal mattress sutures, followed by simple interrupted sutures for optimal tissue adaptation. The healing abutment will act as a mechanical support to maintain space and prevent soft tissue collapse. This tented space is expected to allow blood to accumulate, clot, and gradually reorganize into connective tissue, thereby promoting an increase in vertical soft tissue thickness around the implant. After 2 months , the initial 2-mm healing abutment will be removed, and a 4 mm healing abutment will be placed by mading a small semilunar incision without touching the bone.
TPT-PRF
Procedure/SurgeryIn the PRF group, the same surgical protocol as the TPT group will be followed. However, prior to wound closure, the tented space surrounding the healing abutment will be filled with PRF membranes.
TPT-PBM
Procedure/SurgeryThe PBM group will follow the same surgical protocol as the TPT group. In addition, this group will receive photobiomodulation therapy using red-light irradiation at a wavelength of 630 nm, applied to the occlusal site immediately after surgery and repeated after 7 days.
Group control: implant placement without TPT
Procedure/SurgeryThe negative control group will consist of patients randomly selected from the recruited population, in accordance with the study's inclusion criteria. Participants in this group will not receive any intervention aimed at VST augmentation during implant placement. This will allow for a clear assessment of the effect of the TPT on VST gain and its impact on MBL. In accordance with ethical guidelines, patients in the control group will undergo VST augmentation at a second stage, prior to the initiation of the prosthetic phase.
Treatment groups
Trial outcomes
Primary outcomes
vertical soft tissue height
Marginal BoneLoss
Secondary outcomes
PPD
Pocket probing depth
BOP
Bleeding on probing
PI
Plaque Index
Sponsors and contacts
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University of Santiago de Compostela
Lead sponsor
Galimplant Dental Implants
Collaborator
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