Comparison of Teriparatide and Combination of Cissus Quadrangularis and Dalbergia Sissoo on Bone Healing Against the Control Group in Maxillofacial Fractures: A Randomized Open-label Control Trial
Restricted accessResearch articleFirst published online March, 2023
Comparison of Teriparatide and Combination of Cissus Quadrangularis and Dalbergia Sissoo on Bone Healing Against the Control Group in Maxillofacial Fractures: A Randomized Open-label Control Trial
A randomized control trial was planned to aim to assess whether subcutaneous Injection of Teriparatide and Tablet Reunion (combination of Cissus Quadrangularis and Dalbergia sissoo) improves maxillofacial fracture healing as compared to the control group.
Methods
24 patients of mandibular fracture with or without concomitant maxillofacial fractures were randomly divided into 3 equal groups (Group 1- Control, Group 2- Tablet Reunion, and Group 3- Injection Teriparatide) and the treatment duration was 4 weeks. Pain, fracture site mobility, bite force, serum markers, and radiographic healing were assessed preoperatively and postoperatively at regular intervals till 12 weeks.
Results
Group 2 showed early pain relief, although it was insignificant. Group 3 showed the highest anterior bite force at all the time points. Change in mean posterior bite force (PBF) showed a statistically significant increase at 8th week and 12th week in intergroup comparison; however, at 12th week, Group 3 was significantly better than Group 1 and reported the highest posterior bite force compared to other groups. Serum calcium and PTH level showed no significant difference, whereas Serum ALP showed a statistically significant increase in Group 3. The radiographic assessment showed no significant difference among the 3 groups.
Conclusions
Both the intervention group drugs showed a promising effect on accelerating the fracture healing and improving bite force restoration with the osteoanabolic action; however, early radiographic healing and increased serum osteogenic markers in Group 3 indicate its possible optimistic role in maxillofacial fracture healing.
PetrisorBLissonSSpragueS. Extracorporeal shockwave therapy: A systematic review of its use in fracture management. Indian J Orthop. 2009;43(2):161.
5.
PounderNMHarrisonAJ. Low intensity pulsed ultrasound for fracture healing: A review of the clinical evidence and the associated biological mechanism of action. Ultrasonics. 2008;48(4):330-338.
6.
Della RoccaG. The science of ultrasound therapy for fracture healing. Indian J Orthop. 2009;43(2):121.
7.
BrixenKTChristensenBEjerstedCLangdahlBL. Teriparatide (Biosynthetic Human Parathyroid Hormone 1-34): A New Paradigm in the Treatment of Osteoporosis. Pharmacol Toxicol. 2004;94(6):260-270.
8.
SilvaBCBilezikianJP. Parathyroid hormone: anabolic and catabolic actions on the skeleton. Curr Opin Pharmacol. 2015;22:41-50.
9.
ChanK. Some aspects of toxic contaminants in herbal medicines. Chemosphere. 2003;52(9):1361-1371.
10.
KhedgikarVGautamJKushwahaP, et al.A standardized phytopreparation from an Indian medicinal plant (Dalbergia sissoo) has antiresorptive and bone-forming effects on a postmenopausal osteoporosis model of rat. Menopause. 2012;19:1336-1346.
11.
KushwahaPKhedgikarVGautamJ, et al.A novel therapeutic approach with Caviunin-based isoavonoid that en routes bone marrow cells to bone formation via BMP2/Wnt-b-catenin signaling. Cell Death Dis;16
12.
MigliaccioSBramaMSperaG. The differential effects of bisphosphonates, SERMS (selective estrogen receptor modulators), and parathyroid hormone on bone remodeling in osteoporosis. Clin Interv Aging. 2007;2(1):55-64.
13.
HajareSWSureshCTandanSKSarmaJLalJTelangAG. Analgesic and antipyretic activities of Dalbergia sissoo leaves. Indian J Pharmacol [Internet]. 2000:32(6):357-360. https://www.ijp-online.com/article.asp?issn=0253-7613. Accessed December 29, 2020.
14.
PanthongASupraditapornWKanjanapothiDTaesotikulTReutrakulV. Analgesic, anti-inflammatory and venotonic effects of Cissus quadrangularis Linn. J Ethnopharmacol. 2007;110(2):264-270.
15.
MishraGSrivastavaSNagoriBP. Pharmacological and Therapeutic Activity of Cissus Quadrangularis: An Overview:13.
16.
WaalenJ. Current and emerging therapies for the treatment of osteoporosis. J Exp Pharmacol. 2010:121.
17.
ChenCMLinPYChenYC, et al.Effects of teriparatide on lung function and pain relief in women with multiple osteoporotic vertebral compression fractures. Surg Neurol Int. 2014;5(suppl 7):S339-S342.
18.
KasukawaYMiyakoshiNEbinaT, et al.Enhanced bone healing and decreased pain in sacral insufficiency fractures after teriparatide treatment: retrospective clinical-based observational study. Clinical Cases in Mineral and Bone Metabolism. 2017;14(2):140.
19.
JohanssonT. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. Acta Orthop. 2016;87(1):79-82.
20.
AspenbergPGenantHKJohanssonT, et al.Teriparatide for acceleration of fracture repair in humans: A prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010;25(2):404-414.
21.
VivekGKShettyAVaibhavNImranM. A comparative study of single 3-D titanium plate versus conventional Champy's 2 miniplate fixation in the management of mandibular anterior fracture: A prospective clinical study. Journal of Advanced Clinical & Research Insights. 2016;3(6):194-199.
22.
Al-MoraissiEAMounairRMEl-SharkawyTMEl-GhareebTI. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study. Int J Oral Maxillofac Surg. 2015;44(3):316-321.
23.
SehgalSRamanujamLPrasadKKrishnappaR. Three-dimensional v/s standard titanium miniplate fixation in the management of mandibular fractures - A randomized clinical study. J Cranio-Maxillofacial Surg. 2014;42(7):1292-1299.
SinghNSinghVSinghRPantAPalUMalkunjeL, et al.Osteogenic potential of cissus qudrangularis assessed with osteopontin expression. Natl J Maxillofac Surg. 2013;4(1):52.
26.
SatterwhiteJHeathmanMMillerPDMarínFGlassEVDobnigH. Pharmacokinetics of Teriparatide (rhPTH[1-34]) and Calcium Pharmacodynamics in Postmenopausal Women with Osteoporosis. Calcif Tissue Int. 2010;87(6):485-492.
27.
SinghVPalUMohammadSSinghNDhasmanaSSinghN. Clinical evaluation of cissus quadrangularis and moringa oleifera and osteoseal as osteogenic agents in mandibular fracture. Natl J Maxillofac Surg. 2011;2(2):132.
28.
RasalePLRautSYNarkhedeHPMuddeshwarMG. Biochemical and hormonal evaluation of Cissus quadrangularis in accelerating healing process of bone fracture: A clinical study. Int J Res Ayurveda Pharm. 2014;5:461-469.
29.
ThouvereyCCaverzasioJ. Suppression of p38α MAPK Signaling in Osteoblast Lineage Cells Impairs Bone Anabolic Action of Parathyroid Hormone. J Bone Miner Res. 2016;31(5):985-993.
30.
KhanMJoseASharmaS. Physiology, Parathyroid Hormone. [Internet]. StatPearls , Treasure Island (FL). StatPearls Publishing; 2020. http://www.ncbi.nlm.nih.gov/books/NBK499940/. Accessed December 29, 2020.
31.
BanZ-NLiZ-JGuQ-SChengJHuangQXingS-X. Correlation of serum PTH level and fracture healing speed in elderly patients with hip fracture. J Orthop Surg Res. 2019;14(1):361.
32.
AnastasilakisADPolyzosSAGoulisDGSlavakisAEfstathiadouZKitaM, et al.Endogenous intact PTH is suppressed during Teriparatide (rhPTH 1-34) administration in postmenopausal women with established osteoporosis. Endocr J. 2008;55(3):613-616.
33.
JavinaniAAghaei MeybodiHRKavosiH. Extremely elevated serum alkaline phosphatase level upon treatment with teriparatide: a case report. J Med Case Rep. 2020;14(1):87.
34.
AmolD. Safety and Efficacy of a Standardized Extract from Leaves of Dalbergia sissoo in Healing of Long Bone Fracture: A Pilot Clinical Study. J Complement Med Altern Healthc [Internet]. 2018;5(1). https://juniperpublishers.com/jcmah/JCMAH.MS.ID.555654.php. Accessed December 22, 2020.
35.
BrahmkshatriyaHRShahKAAnanthkumarGBBrahmkshatriyaMH. Clinical evaluation of Cissus quadrangularis as osteogenic agent in maxillofacial fracture: A pilot study. Ayu. 2015;36(2):169-173.
36.
KimS-MKangK-CKimJWLimS-JHahnMH. Current Role and Application of Teriparatide in Fracture Healing of Osteoporotic Patients: A Systematic Review. Journal of Bone Metabolism. 2017;24(1):65.
