Trial · Interventional

Status unknownPhase 4Registry data

Teriparatide on Maxillary Sinus Floor Osseointegration

NCTNCT06061354Other idCEC 256-22

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 42 participants (estimated)
Sponsor: Universidad de Valparaiso · Other
Design: Randomized · Double masking
Countries: 1 country
Chile
Start: 23 Aug 2023
Primary completion: Aug 2024 (estimated)
Completion: Dec 2024 (estimated)
First posted: 29 Sept 2023
Last update posted: 30 Nov 2023
Conditions: Bone Regeneration

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 4
Teriparatide on Maxillary Sinus Floor Osseointegration
NCT06061354
23 Aug 2023 to est. Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. The sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®). Three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. These bone cores will be submitted to histological and histomorphometric analysis. The stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (Ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.

Interventions

TeriparatideDrug
Maxillary Sinus AugmentationProcedure
Dental Implant InstallationProcedure
Bone graftCombination product

Arms2

Experimental
Teriparatide
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane. Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
Placebo comparator
Placebo
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material, Bio-Oss® mixed with saline solution, will be delivered for placement on the sinus floor maxilla below Schneider's membrane. Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed

Primary outcomes1

Outcomes the sponsor listed as primary.

Histology
Time frame · 3 months
Registry description
osteoblasts/mm2

Secondary outcomes(1)

Histomorphometry
Time frame · 3 months
Registry description
Describe de presence of following parameters: necrosis, inflammation, vascularization and angiogenesis, fibrosis, presence of medullary adipose tissue, new bone formation and foreign body reaction

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies20

Studies that cite this trial.

Studies with results

9 studies on this page

Indexing hint: Animal study · 2023

14 results

Abaloparatide outperforms teriparatide in protecting against alveolar bone loss in experimental periodontitis.

Li et al. 2023Journal of periodontologycited by 11

PMID 35892139DOI 10.1002/jper.22-0211PUB-35892139

Full text at the publisher14 results

Publisher page See results (14)

Indexing hint: Randomized controlled trial · 2022

2 results

The efficacy of teriparatide (Cinnopar®) on bone repair in mandibular fractures: A single blinded randomized clinical trial.

Ebrahimi et al. 2022Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgerycited by 1

PMID 36646571DOI 10.1016/j.jcms.2022.12.002PUB-36646571

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Animal study · 2019

8 results

Effect of intermittent teriparatide (PTH 1-34) on the alveolar healing process in orchiectomized rats.

de Oliveira et al. 2019Clinical oral investigationscited by 18

PMID 30291494DOI 10.1007/s00784-018-2672-yPUB-30291494

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Animal study · 2019

8 results

Combined effects of systemic parathyroid hormone (1-34) and locally delivered neutral self-assembling peptide hydrogel in the treatment of periodontal defects: An experimental in vivo investigation.

Yoshida et al. 2019Journal of clinical periodontologycited by 22

PMID 31292977DOI 10.1111/jcpe.13170PUB-31292977

Rights unknown8 results

Source link See results (8)

Indexing hint: Animal study · 2016

5 results

Histopathological Effects of Teriparatide in Medication-Related Osteonecrosis of the Jaw: An Animal Study.

Keskinruzgar et al. 2016Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeonscited by 22

PMID 26215490DOI 10.1016/j.joms.2015.07.005PUB-26215490

Full text at the publisher5 results

Publisher page See results (5)

PubMed tag: none · 2015

3 results

Administration of teriparatide improves the symptoms of advanced bisphosphonate-related osteonecrosis of the jaw: preliminary findings.

Kakehashi et al. 2015International journal of oral and maxillofacial surgerycited by 35

PMID 26304604DOI 10.1016/j.ijom.2015.07.018PUB-26304604

Full text at the publisher3 results

Publisher page See results (3)

Indexing hint: Observational study · 2014

6 results

Teriparatide and the treatment of bisphosphonate-related osteonecrosis of the jaw: a rat model.

Ersan et al. 2014Dento maxillo facial radiologycited by 30

PMID 24170800PMC3887480DOI 10.1259/dmfr.20130144PUB-24170800

Rights unknown6 results

Source link See results (6)

Indexing hint: Randomized controlled trial · 2011

6 results

Short-term teriparatide delivery and osseointegration: a clinical feasibility study.

Kuchler et al. 2011Journal of dental researchcited by 33

PMID 21555773DOI 10.1177/0022034511407920PUB-21555773

Full text at the publisher6 results

Publisher page See results (6)

PubMed tag: none · 2010

4 results

Effect of intermittent systemic administration of recombinant parathyroid hormone (1-34) on mandibular fracture healing in rats.

Rowshan et al. 2010Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeonscited by 46

PMID 20116693DOI 10.1016/j.joms.2009.09.045PUB-20116693

Lima et al. 2013Clinical oral implants researchcited by 10

PMID 22712894DOI 10.1111/j.1600-0501.2012.02502.xPUB-22712894

Full text at the publisher

Publisher page

PubMed tag: none · 2012

Effect of intermittent PTH(1-34) on human periodontal ligament cells transplanted into immunocompromised mice.

Wolf et al. 2012Tissue engineering. Part Acited by 14

PMID 22497226PMC3432899DOI 10.1089/ten.tea.2011.0626PUB-22497226

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: All
Age: from 25 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Pneumatization of a maxillary sinus with a residual ridge ≤ 5 mm in height (according to baseline conebeam tomograph). * Must sign an informed consent to participate in this study. Exclusion Criteria: * Residual ridges less than 4 mm in height. * Uncontrolled systemic disease (ASA 3, 4, 5, and 6) * Presenting with osteoporosis or any disease of bone metabolism. * Having received radiotherapy. * Cancer. * Any systemic condition that affects calcium absorption. * Kidney disease. * Coagulation disorders. * History of sinusitis. * Maxillary sinus pathology. * Heavy smoking (\> 1 pack per day). * Drug or alcohol users. * Pregnancy. * Treatment with drugs that affect bone metabolism. * Treatment with immunosuppressants. * Allergies. * Uncontrolled periodontal pathology. * Tooth extractions in the last three months.

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