DRUG
Teriparatide
mixture of 20μg of teriparatide, 0.64ml of saline solution with 1g of Bio -Oss® or 1g of Bio-Oss® will be mixed with 0.72ml of saline solution.
Teriparatide on Maxillary Sinus Floor Osseointegration
Status
Unknown
Phase
Phase 4
Enrollment
42
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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
Treatment arms and agents.
PROCEDURE
Maxillary Sinus Augmentation
Local anesthesia will be performed, mucoperiosteal flap will be raised to access the anterior wall of the maxillary sinus. Access to the maxillary sinus will be done through osteotomy, using a piezosurgery under irrigation with saline solution. Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material (Bio-Oss® mixed with saline solution or 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.
PROCEDURE
Dental Implant Installation
Local anesthesia will be performed a mucoperiosteal flap will be raised in the area for implant placement and a bone core 10 mm high and 2 mm in diameter will be removed with a 2 mm trephine bur. The bone biopsied through this nucleus is part of the region where the implant will be installed, and the height of the sample depends on the surgical planning carried out previously (3-month radiographic control). The sequence of drills to place the implant will continue, installation of the implant itself and, finally, verification of the insertion torque and measurement of the resonance frequency in the already installed implant. The mucoperiosteal flap must be repositioned and sutured.
COMBINATION_PRODUCT
Bone graft
One arm:mixture of 20μg of teriparatide, 0.64ml of saline solution with 1g of Bio -Oss® In other arm: 1g of Bio-Oss® will be mixed with 0.72ml of saline solution.
Timeline
From registration to results.
First posted
Sep 29, 2023
Study start
Aug 23, 2023
Primary completion
Aug 2024
Study completion
Dec 2024
Results posted
Not reported
Registry updated
Nov 30, 2023
Outcomes
What the study measures.
Primary outcomes
Histology
Time frame · 3 months
osteoblasts/mm2
Secondary outcomes
Histomorphometry
Time frame · 3 months
Describe de presence of following parameters: necrosis, inflammation, vascularization and angiogenesis, fibrosis, presence of medullary adipose tissue, new bone formation and foreign body reaction
Eligibility
Who can take part.
- Minimum age
- 25 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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.
Study locations
1 registered sites.
Chile. Showing up to 24 locations stored in the fast local snapshot.
Facultad de Odontología, Universidad de Valparaiso
Valparaíso, Valparaiso, Chile
Publications
Results and literature.
PMID 9240383 ↗Miller SC, Hunziker J, Mecham M, Wronski TJ. Intermittent parathyroid hormone administration stimulates bone formation in the mandibles of aged ovariectomized rats. J Dent Res. 1997 Aug;76(8):1471-6. doi: 10.1177/00220345970760080901.PMID 15515341 ↗Boabaid F, Berry JE, Koh AJ, Somerman MJ, McCcauley LK. The role of parathyroid hormone-related protein in the regulation of osteoclastogenesis by cementoblasts. J Periodontol. 2004 Sep;75(9):1247-54. doi: 10.1902/jop.2004.75.9.1247.PMID 17386063 ↗Jung RE, Cochran DL, Domken O, Seibl R, Jones AA, Buser D, Hammerle CH. The effect of matrix bound parathyroid hormone on bone regeneration. Clin Oral Implants Res. 2007 Jun;18(3):319-25. doi: 10.1111/j.1600-0501.2007.01342.x. Epub 2007 Mar 26.PMID 19046622 ↗Liu J, Cao Z, Li C. Intermittent PTH administration: a novel therapy method for periodontitis-associated alveolar bone loss. Med Hypotheses. 2009 Mar;72(3):294-6. doi: 10.1016/j.mehy.2008.10.015. Epub 2008 Nov 30.PMID 20116693 ↗Rowshan HH, Parham MA, Baur DA, McEntee RD, Cauley E, Carriere DT, Wood JC, Demsar WJ, Pizarro JM. Effect of intermittent systemic administration of recombinant parathyroid hormone (1-34) on mandibular fracture healing in rats. J Oral Maxillofac Surg. 2010 Feb;68(2):260-7. doi: 10.1016/j.joms.2009.09.045.PMID 20429653 ↗Valderrama P, Jung RE, Thoma DS, Jones AA, Cochran DL. Evaluation of parathyroid hormone bound to a synthetic matrix for guided bone regeneration around dental implants: a histomorphometric study in dogs. J Periodontol. 2010 May;81(5):737-47. doi: 10.1902/jop.2010.090562.PMID 21908105 ↗Zeng X, He H, Zhang L, Wu Y, Wang Y, Gong P. A potential therapeutic approach to overload-induced bone loss around implant: parathyroid hormone (PTH). Med Hypotheses. 2011 Nov;77(5):701-4. doi: 10.1016/j.mehy.2011.06.016. Epub 2011 Sep 9.PMID 21555773 ↗Kuchler U, Luvizuto ER, Tangl S, Watzek G, Gruber R. Short-term teriparatide delivery and osseointegration: a clinical feasibility study. J Dent Res. 2011 Aug;90(8):1001-6. doi: 10.1177/0022034511407920. Epub 2011 May 9.PMID 22727105 ↗Ali MN, Kobayashi T, Tanaka M, Ohshima H, Ejiri S, Saito C. Effects of intermittent parathyroid hormone treatment on new bone formation during distraction osteogenesis in the rat mandible. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jul;114(1):e36-42. doi: 10.1016/j.oooo.2011.08.009. Epub 2012 Feb 25.PMID 21895887 ↗Aggarwal P, Zavras A. Parathyroid hormone and its effects on dental tissues. Oral Dis. 2012 Jan;18(1):48-54. doi: 10.1111/j.1601-0825.2011.01850.x. Epub 2011 Sep 6.PMID 22497226 ↗Wolf M, Lossdorfer S, Abuduwali N, Meyer R, Kebir S, Gotz W, Jager A. Effect of intermittent PTH(1-34) on human periodontal ligament cells transplanted into immunocompromised mice. Tissue Eng Part A. 2012 Sep;18(17-18):1849-56. doi: 10.1089/ten.TEA.2011.0626. Epub 2012 May 21.PMID 23071071 ↗Chan HL, McCauley LK. Parathyroid hormone applications in the craniofacial skeleton. J Dent Res. 2013 Jan;92(1):18-25. doi: 10.1177/0022034512464779. Epub 2012 Oct 15.
Related trials
More studies on Teriparatide.
NCT IDStudyPhase / statusEnrollmentUpdated
Sequential Therapies After Osteoanabolic Treatment
424 General Military Hospital · Osteoporosis, Postmenopausal
Not applicable
Recruiting
150
2026-07
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
Syneos Health · Healthy Volunteers
Phase 1
Recruiting
48
2026-07
Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid
University of Edinburgh · Osteogenesis Imperfecta
Phase 4
Completed
350
2026-06
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action
Sheffield Teaching Hospitals NHS Foundation Trust · Osteoporosis
Phase 4
Completed
19
2026-05
Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
The University of Hong Kong · Osteoporosis · Fusion of Spine, Lumbar Region
Not applicable
Active, not recruiting
192
2026-05
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
Madhumathi Rao · Age-Related Osteoporosis
Phase 4
Active, not recruiting
60
2026-05
A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens
Shenzhen Salubris Pharmaceuticals Co., Ltd. · Postmenopausal Women With Osteoporosis
Phase 2
Recruiting
200
2026-05
Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis
University Health Network, Toronto · Osteoporosis
Not applicable
Active, not recruiting
100
2026-05
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.