Clinical trial NCT07018531: Vertical Soft Tissue Augmentation With Tent Pole Technique and Its Influence on Marginal Bone Loss Around Dental Implants
Official title: Vertical Soft Tissue Augmentation Using the Tent-Pole Technique With Adjunctive Therapies and Its Influence on Marginal Bone Loss Around Dental Implants: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Soft Tissue Augmentation Around Dental Implants
Keywords: Dental Implants
Vertical Soft Tissue
Tent Pole Technique
Platelet-Rich Fibrin
Photobiomodulation
Marginal Bone Loss
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Galimplant Dental Implants
First posted: 2025-06-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Thin vertical soft tissues (VST) around dental implants pose a clinical challenge due to their strong association with marginal bone loss (MBL). Current evidence suggests that a minimum of 3 mm of VST height is essential to ensure peri-implant bone stability. Several techniques have been proposed to augment soft tissue thickness and reduce MBL, including connective tissue grafts, membranes, platelet-rich fibrin (PRF), and the Tent Pole Technique (TPT), which uses a 2 mm healing abutment to tent the soft tissue. This randomized controlled clinical trial aims to assess the effectiveness of the TPT when performed simultaneously with implant placement, in comparison to a non-intervention control group, for vertical soft tissue augmentation. Additionally, the study evaluates the impact of two adjunctive therapies: photobiomodulation (PBM) and PRF combined with TPT. In fact, PBM involves the application of low-level laser therapy at a wavelength of 630 nm to the occlusal site immediately after surgery and again at day 7, with the goal of enhancing cellular activity, accelerating healing, and promoting soft tissue regeneration. PRF, an autologous concentrate rich in growth factors, is used to fill the space created by the healing abutment in the TPT, further supporting tissue regeneration. The study includes four groups: TPT alone, TPT combined with PBM, TPT combined with PRF, and a control group without soft tissue intervention. The hypothesis is that TPT is effective in increasing vertical soft tissue thickness and maintaining marginal bone levels, and that its combination with either PBM or PRF may further enhance clinical outcomes both in the short and long term.

Eligibility criteria: Inclusion Criteria:

* 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.
* Buccal bone thickness must be at least 1.5 mm.

Exclusion Criteria:

* 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.
* History of conditions or diseases that compromise bone metabolism (e.g. Paget's disease, osteoporosis) or current use of medications that may affect bone metabolism (e.g. bisphosphonates).
* History of cancer or prior radiotherapy or chemotherapy treatments for malignancy.
* Uncontrolled diabetes.
* Current pregnancy or breastfeeding status.
* Allergies to any products involved in the study.

Primary outcomes:
measure: vertical soft tissue height
timeFrame: 2 months , 4 months and 6 months
measure: Marginal BoneLoss
timeFrame: 2 months, 4 months, 6 months
Secondary outcomes:
measure: PPD
timeFrame: 6 months
measure: BOP
timeFrame: 6 months
measure: PI
timeFrame: 6 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Oral Medicine, Oral Surgery and Implantology Unit (Medoralres), Faculty of Medicine and Dentistry, University of Santiago de Compostela
state: A Coruña
city: Monastir
country: Tunisia
facility: Oral Health and Oral Rehabilitation Research Laboratory, LR12ES11, Faculty of Dental Medecine of Monastir, University of Monastir
Study officials:
References: