Xenogenic Bone Intentionally Left Exposed

NCT06191510 | Completed

• 1 other identifier: CAAE: 21305419.1.0000.5419
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare, the effect of letting the xenogeneic bone graft exposed to the oral environment or seal off the graft with a collagen matrix. Them main questions it aims to answer are:

• The enhancement of soft tissue healing during the initial phases following immediate implant placement.
• The secondary aim is to evaluate the dimensional alterations in hard tissues at immediately placed implants and different biomaterial protocol. It were selected patients with indication of flapless extraction in posterior teeth, which was placed immediate implant (n=28) and gap filling with deproteinized bovine bone mineral (Geistlich Bio-Oss®). In this study, participants were stratified into two randomized blocks, each corresponding to a distinct surgical technique: left exposed the graft to the oral environment or coverage with a collagen matrix (Geistlich Mucograft®).
• Previously the extraction was performed the measurement of the keratinized gingiva, and after 04 months of implant placement.
• The soft tissue healing was evaluated on days 02, 07, 30 days; by means of a blue-stained solution (methylene blue 0.05%) and standardized photograph.
• In the same date from different healing times it was performed immunoenzymatic analysis of the levels of VEGF (vascular endothelial growth factor), IL-1β (interleukin-1β) and FGF2 (fibroblast growth factor 2).
• It was also be performed cone beam computed tomography images quantifying the soft and hard tissues thickness of the facial and lingual bone wall. The clinical trial examiner was blinded during the study period.

Conditions

Soft Tissue; Dental Implants; Healing Wound

Keywords

Molar site; Alveolar Bone Loss; Tissue Conditioning, Dental; Biomaterials

Outcome Measures

Primary Outcomes (1)

• Keratinized Mucosa Width

  The keratinized mucosa width was evaluated using a periodontal probe at the facial level before extraction and after 4 months at the implant placement.

  before extraction, after 1-2 months post implant placement, and after the emergence contour of a prosthesis (up to 4 months).

Secondary Outcomes (1)

• Cone Beam Computed Tomographs Measurements

  Baseline; after 4 months

Other Outcomes (2)

• Clinical Assessment of Epithelialization

  2 day, 1 week, and 1 month after the implant placement

• Serum levels of cytokines

  2 day, 1 week, and 1 month after the implant placement

Study Arms (2)

Experimental Group

The aim of this study is to assess the effectiveness of usage of xenogeneic bone intentionally left exposed to the oral environment after immediate implant placement in preserving keratinized mucosa and the alveolar ridge height and width preservation, without compromising the healing process.

Procedure: Bio-Oss Exposed

Control group

The aim of this study is to evaluate whether the use of collagen matrix has benefits when compared to xenogeneic bone intentionally left exposed to the oral environment after immediate implant placement.

Procedure: Mucograft Exposed

Interventions

Bio-Oss Exposed PROCEDURE

Molar extraction with a flapless approach and immediate implant installation, filling the gap with deproteinized bovine bone mineral (Geistlich Bio-Oss) and left exposed to the oral environment.

Also known as: Immediate Implant Placement Associated with biomaterials

Experimental Group

Mucograft Exposed PROCEDURE

Molar extraction with a flapless approach and immediate implant installation, filling the gap with deproteinized bovine bone mineral (Bio-Oss; Geistlich) and covered by a collagen matrix (Mucograft; Geistlich).

Also known as: Immediate Implant Placement Associated with biomaterials

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hopeless molar teeth who are scheduled for immediate implant placement in this area, in the researcher's town.

You may qualify if:

• Healthy adults (≥18 years-old) exhibiting good oral hygiene,
• Hopeless molar teeth with an intact buccal socket wall,
• Sufficient apical bone allowing for immediate implant placement.

You may not qualify if:

• Individuals with systemic diseases that are unstable,
• Uncontrolled metabolic conditions,
• Daily smoking habit of ≥10 cigarettes,
• Those who have received antibiotic drugs or corticosteroids within the past 3 months, or are currently on medications that impact bone healing, such as bisphosphonates,
• Patients with a past history of chemotherapy or radiation therapy in the oral and maxillofacial region.

Sponsors & Collaborators

• University of Sao Paulo: lead
• São Paulo State University: collaborator
• Universidade Federal de Sergipe: collaborator

Study Sites (1)

School of Dentistry of Ribeirão Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Biocompatible Materials

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Valessa F Carvalho, PhD student

  School of Dentistry of Ribeirão Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, Ms, DDs. Chairman of Periodontolgy

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: December 17, 2019
• Primary Completion: April 14, 2022
• Study Completion: June 15, 2022
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)