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

January 4, 2024 updated by: Francisco Javier Rodriguez Lozano, Universidad de Murcia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Murcia, Spain, 30009
        • Recruiting
        • Universidad de Murcia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laterally Rotated Flap
LRF, Moreno and Caffesse, 2016
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.
Active Comparator: Free gingival graft
FGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in soft tissue 6months after procedure
Time Frame: 1 year
The amount of soft tissue gained in millimeters will be measured before and after
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Investigators

  • Principal Investigator: JOSE ANTONIO MORENO RODRÍGUEZ, DDS, UNIVERSIDAD DE MURCAI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 4, 2024

Primary Completion (Estimated)

September 29, 2024

Study Completion (Estimated)

October 29, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2586/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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