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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206499
• Other study ID #: 2586/2019
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: October 29, 2024

Study information

• Verified date: January 2024
• Source: Universidad de Murcia
• Contact: MIGUEL RAMÓN P PECCI LLORET, PhD
• Phone: 630492610
• Email: miguelr.pecci[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in soft tissue 6months after procedure	The amount of soft tissue gained in millimeters will be measured before and after	1 year