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Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant

NCT06206499 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-16

No results posted yet for this study

Summary

Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Furthermore, a significant association was found between peri-implant mucositis, and smoking, implant maintenance and peri-implant soft tissue characteristics (Wada et al. 2019).

Soft tissue quality and volume of the peri-implant mucosa are considered important factors in the prognosis of osseointegrated implants. Linkevicius et al. showed that if its soft tissue thickness was less than 2 mm, crestal bone loss might occur (Linkevicius et al. 2009). In addition, when soft tissue width was evaluated, a wider soft tissue band was related to minimal bone remodeling (Linkevicius et al. 2015). Lin et al. reported in a systematic review and meta-analysis that a lack of keratinized tissue (KT) around osseintegrated implants was associated with plaque accumulation, peri-implant tissue inflammation, soft tissue recession and attachment loss (Lin et al. 2013). Moreover, recent studies established the need of a minimal band of 2 mm of KT around osseointegrated implants, and showed that a band less than 2 mm was associated with more brushing discomfort, plaque accumulation, tissue inflammation and marginal bone apical displacement, concluding that a KT\>2 mm had a protective effect on peri-implant tissues (Souza et al. 2015, Perussolo et al. 2018, Monje et al. 2019). Furthermore, peri-implant tissue diseases have also been related to an irregular compliance in situations of lack of KT (Monje et al. 2019).

In the presence of peri-implant horizontal and/or vertical soft tissue deficiencias, soft tissue augmentation has been considered a priority, even prior or instead of bone augmentation (Burkhardt et al. 2008, Zucchelli et al. 2013).

Conditions

  • Implant Tissue Failure
  • Dental Implant Failed
  • Peri-Implantitis

Interventions

PROCEDURE

soft tissue augmentation

Laterally Rotated Flap: A Split-thickness recipient bed on the buccal and mesial aspects of the implant was prepared, resulting in a firm attached bleeding area. The extension of the incisions towards the palate and the distance between them are dependent on the amount of keratinized tissue graft needed for each particular case. Habitually, the keratinized tissue is taken from the adjacent crest; however, if needed to displace more tissue, the incisions may be extended into the palatal tissue. The flap was prepared partial thickness, and released apically from the periosteum to allow passive displacement, and suturing without tension. It was latero-mesially displaced with a 90º rotation. The pedicle was sutured to the recipient bed. Control group: The surgical procedure followed the design proposed by Sullivans \& Atkins 1968 for soft tissue augmentation around teeth and modified by for application around oseointegrated dental implants.

Sponsors & Collaborators

  • Universidad de Murcia

    lead OTHER

Principal Investigators

  • JOSE ANTONIO MORENO RODRÍGUEZ, DDS · UNIVERSIDAD DE MURCAI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2024-09-29
Completion
2024-10-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206499 on ClinicalTrials.gov