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

NCT06206499 | Unknown DMC

• 1 other identifier: 2586/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in soft tissue 6months after procedure

  The amount of soft tissue gained in millimeters will be measured before and after

  1 year

Study Arms (2)

Laterally Rotated Flap

EXPERIMENTAL

LRF, Moreno and Caffesse, 2016

Procedure: soft tissue augmentation

Free gingival graft

ACTIVE COMPARATOR

FGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989

Procedure: soft tissue augmentation

Interventions

soft tissue augmentation PROCEDURE

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.

Free gingival graft; Laterally Rotated Flap

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy-Lactation Relevant systemic disease

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Universidad de Murcia

Murcia, 30009, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• JOSE ANTONIO MORENO RODRÍGUEZ, DDS

  UNIVERSIDAD DE MURCAI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MIGUEL RAMÓN P PECCI LLORET, PhD

CONTACT

630492610; miguelr.pecci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: April 4, 2024
• Primary Completion: September 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

ES (1)