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Sponsor study identifier
interventional
30
1 country
1
Study Start
April 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2024
Actual (reported)January 16, 2024
Actual (reported)April 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in soft tissue 6months after procedure
The amount of soft tissue gained in millimeters will be measured before and after
1 year
LRF, Moreno and Caffesse, 2016
FGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universidad de Murcia
Murcia, 30009, Spain
JOSE ANTONIO MORENO RODRÍGUEZ, DDS
UNIVERSIDAD DE MURCAI
First Submitted
January 4, 2024
First Posted
January 16, 2024
Study Start
April 4, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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September 29, 2024
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Study Completion
October 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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