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

U

Universidad de Murcia

Status

Enrolling

Conditions

Dental Implant Failed
Implant Tissue Failure
Peri-Implantitis

Treatments

Procedure: soft tissue augmentation

Study type

Interventional

Funder types

Other

Identifiers

NCT06206499
2586/2019

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

implant with soft tissue recession Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day)

Exclusion criteria

Pregnancy-Lactation Relevant systemic disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

Laterally Rotated Flap
Experimental group
Description:
LRF, Moreno and Caffesse, 2016
Treatment:
Procedure: soft tissue augmentation
Free gingival graft
Active Comparator group
Description:
FGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989
Treatment:
Procedure: soft tissue augmentation

Trial contacts and locations

1

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Central trial contact

MIGUEL RAMÓN P PECCI LLORET, PhD

Data sourced from clinicaltrials.gov

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