Vertical Soft Tissue Augmentation With Tent Pole Technique and Its Influence on Marginal Bone Loss Around Dental Implants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Santiago de Compostela

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • VST augmentation with TPT

    Procedure/Surgery

    For 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/Surgery

    In 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/Surgery

    The 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/Surgery

    The 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

112 Participants
are divided into 4 treatment groups
Group A: Tent pole techniqueExperimental treatment 1 intervention
Group B: Tent pole technique with platelet-rich fibrinExperimental treatment 1 intervention
Group C: Tent pole technique with photobiomodulationExperimental treatment 1 intervention
Group D: Negative control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

vertical soft tissue height

Time frame
2 months , 4 months and 6 months
2

Marginal BoneLoss

Time frame
2 months, 4 months, 6 months

Secondary outcomes

1

PPD

Pocket probing depth

Time frame
6 months
2

BOP

Bleeding on probing

Time frame
6 months
3

PI

Plaque Index

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Santiago de Compostela

Lead sponsor

Galimplant Dental Implants

Collaborator

This trial is not recruiting at the moment. You can still explore other options: