Impact of PTFE-d Barrier Intentionally Exposed to Bucal Environment in Guided Bone Regeneration to Ridge Preservation

NCT04329351 | Unknown DMC

• 1 other identifier: GBR-barrier exposed
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this clinical-laboratorial, paralel, randomized, prospective and controlled study was determine the impact of of PTFE-d barrier intentionally exposed to bucal environment in guided bone regeneration to ridge preservation, using microbiological, radiographic, patient-centered outcomes, molecular patter of bone-related markers and implant stabilization. Fourty individuals with tooth extraction indication and subsequent implant placement between upper pre-molars were recruited. Patients were randomly allocated in one of this groups, following tooth extraction: 1) GBR: sockets received GBR with d-PTFE membranes which was maintained intentionally exposed to bucal environment and removed after 28 days; and 2) Non-GBR: sockets did not receive additional therapy after extration. After 3 months, all patients received dental implants and temporary implant-supported prostheses. Patient-reported outcomes in terms of morbidity, swelling and interference with daily life were recorded at 3, 7, 14, 28, 35 and 42 days following dental extraction and in terms of esthetic outcomes after prosthesis instalation by using questionaries. Samples of biofilm at surface repair/barrier were obtained in both groups at 3 and 28 days after extraction (in the moment of barrier removal) to microbiological evaluation using Illumina HiSeq system. Computed tomography obtained imediatlly after extraction and before implant placement will be analised to evaluation of changes on ridge dimensions. After 3 months following extration, bone tissue biopsies will be harvested from the sites designed to receive dental implants to evaluation of imunoenzimatic pattern (DKK1, OPG, OC, OPN, TNF-α, SOST, RANKL, OSN e TRAP) and gene expression (TGF-β, BSP e COL-I) of bone-related markers using Luminex/Magpix and PCR Real-Time, respectivally. Afer imlpant placement, the implant stability quotient (ISQ) was determined. The results will be statistically compared after normality test, with the level of significance set at 5%.

Conditions

Ridge Preservation

Keywords

Alveolar Bone Loss; guided bone regeneration

Outcome Measures

Primary Outcomes (1)

• tomographic changes in bone height

  tomographic changes in bone height

  baseline and at 3-month

Secondary Outcomes (6)

• Clinical attachament level

  baseline and at 3-month

• Probing Depth (PPD/mm)

  baseline and at 3-month

• Microbioma analysys

  3 days and 28 days

• patient-centered parameters

  3, 7, 14, 28, 35 and 42 days

• Gene expression analysis of markers related to osteoclast / blastogenesis

  3 months

Study Arms (2)

Guided bone regeneration Group

EXPERIMENTAL

After extraction, Guided bone regeneration was conducted using the PTFE-d membrane (CytoplastTM Ti-250 Titanium-Reinforced, Anterior Narrow 12 mm x 24 mm, Osteogenics, Lubbock, TX, USA) was customized with scissors and adjusted over the socket, exceeding three millimeters from its margins. Then, the membrane was inserted subperiostally under the buccal and palatal flaps with the help of the Molt detacher. Minimal flap reflection was performed to stabilize the membrane, which was maintained intentionally exposed to the oral environment. Before suturing, the passive stability of the membrane over the alveolus was confirmed, as well as the absence of folds or wrinkles in the membrane. The flaps were then be approached in the pre-extraction position and sutured with crossed sutures, aiming to increase the stability of the membrane, with PTFE 4-0 thread (Cytoplast PTFE, CS0618PREM, Osteogenics, Lubbock, TX, USA).

Procedure: Guided Bone regeneration

Non-Guided bone regeneration group

PLACEBO COMPARATOR

After extraction, no further treatment (No addition of Guided bone regeneration) was performed. The flaps were then repositioned and sutured with 5.0 nylon thread (Ethicon, Jonhson's Jonhson, São José dos Campos).

Procedure: Guided Bone regeneration

Interventions

Guided Bone regeneration PROCEDURE

Guided bone regeneration to ridge preservation

Guided bone regeneration Group; Non-Guided bone regeneration group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged between 30 and 70 years old
• with a tooth indicated for extraction and subsequent rehabilitation with dental implant
• tooth extraction should be related to one of the teeth between maxillary premolars (premolar, canine, lateral or central incisor)
• the reasons for extraction may include the impossibility of restorations due to the presence of extensive caries lesions, prosthetic failures, root fractures or endodontic failures.
• the region to receive implants must present, radiographically, bone dimensions that allow the future placement of the dental implant and adequate prosthetic space for the subsequent prosthetic rehabilitation.
• at least three bone walls must be present at the time of extraction.

You may not qualify if:

• pregnancy
• lactation
• current smoking or ex-smokers
• other systemic conditions that could affect bone metabolism (e.g., immunologic disorders)
• use of anti-inflammatory, bisphosphonate and immunosuppressive medications.

Sponsors & Collaborators

• Fernanda Vieira Ribeiro: lead

Study Sites (2)

School of Dentistry - Paulista University UNIP

São Paulo, São Paulo, 052, Brazil

Location

Fernanda Vieira Ribeiro

São Paulo, São Paulo, 055, Brazil

Location

Related Publications (2)

• Braz SHG, Monteiro MF, Matumoto EK, Correa MG, Casarin RCV, Ribeiro FV, Cirano FR, Casati MZ, Pimentel SP. Microbial colonization in the partially exposed nonabsorbable membrane during alveolar ridge preservation. Clin Oral Investig. 2024 Jun 14;28(7):373. doi: 10.1007/s00784-024-05763-7.

  PMID: 38874776 DERIVED

• Matumoto EK, Correa MG, Couso-Queiruga E, Monteiro MF, Graham Z, Braz SHG, Ribeiro FV, Pimentel SP, Cirano FR, Casati MZ. Influence of partially exposed nonabsorbable membrane for alveolar ridge preservation: A randomized controlled trial. Clin Implant Dent Relat Res. 2023 Jun;25(3):447-457. doi: 10.1111/cid.13202. Epub 2023 Mar 22.

  PMID: 36946359 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Zaffalon Casati Marcio

  Paulista University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, MS, PHD, Professor

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: June 1, 2018
• Primary Completion: March 13, 2020
• Study Completion: December 20, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)