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Journal of Oral Science & Rehabilitation No. 4, 2016

Journal of Oral Science & Rehabilitation 64 Volume 2 | Issue 4/2016 E f f e c t s o f i n s e r t i o n t o r q u e o n h a r d a n d s o f t t i s s u e a f t e r t w o y e a r s changes.The nullhypothesiswasthattherewas no difference in the facial soft-tissue changes between the two buccal plate groups (thickness < 1 mm vs. thickness > 1 mm), against the alter- native hypothesis that there was a difference. The present studywas designed accordingto the CONSORTStatementforparallel-group ran- domized trials.13 Materials and methods Partially edentulous patients who were 18 years old orolderand ableto sign an informed consent form and required at least one single implant- supported delayed restoration were considered eligibleforinclusion inthetrial.Allofthe patients were recruitedfromthe consultation clinic atthe Dentistry Department of Versilia Hospital, Uni- versity of Pisa, Pisa, Italy, from July 2011 to De- cember 2012. This study was designed as a par- allel-arm randomized controlled clinicaltrial and consecutively treated patients were included. The exclusion criteria were – history of systemic diseases that would con- traindicate oral surgery; – long-termnonsteroidalanti-inflammatorydrug therapy; – intravenous and oral bisphosphonate therapy; – lack ofoccluding dentition inthe area intended for the restoration; – extraction siteswith lessthanthree months of healing; – untreated periodontal disease; – need for bone augmentation at the time of im- plant surgery; – poororalhygiene and compliance (presence of stains, calculus and plaque before surgery); – pregnant or nursing; – unwillingness to return for the follow-up examination; and – smokingmorethantencigarettesperday(sub- jects who smoked fewer than ten cigarettes perdaywererequestedtostopsmokingbefore and after surgery; however, their compliance could not be monitored). The studyfollowed the principles outlined in the Declaration of Helsinki of 1975, as revised in 2013, on clinical research involving human sub- jects and was approved by the local ethics com- mittee. Demographic data are summarized in Table 1. All of the patients received a thorough explanation and had to complete a written informed consent form prior to being enrolled in the trial. Patients included in the study were accurately evaluated by examining the clinical aspects and periapicalorpanoramic radiographs and underwent computed tomography scan examination, if required. After the consent form had been signed, all of the patients underwent at least one oral hygiene session in order to pro- videamorefavorableoralenvironmentforwound healing. Impressions of the selected jaws were taken, in orderto adequately plan the prosthesis and obtain a stable occlusion. Clinical and radiographic evaluations were performed to select patients with an amount of bone adequate for implant placement. Patient recruitment and treatment were performed by two well-trained surgeons (AB and FA), who received training before starting the study. The training included calibration for surgical, pro- sthetic and follow-up procedures, as well as the management of any complications. Patientswere randomlyallocated byopening asequentiallynumberedenvelopecorresponding to the patients’ recruitment numbers, either to the high insertion torque group or to the regular insertiontorque group.The high insertiontorque groupreceivedaself-tappingdesignimplant(CT, Intra-Lock International, Boca Raton, Fla., U.S.), which had an insertion torque value ≥ 50 N cm. The regular insertion torque group received a modified cutting flute design implant (Blossom CT, Intra-Lock International),which had an inser- tion torque value < 50 N cm. The thread design of the two implants was identical, only differing regarding the cutting groove design. A computer-generated restricted random- izationlistwascreated.Oneinvestigator(PT),who wasnotinvolvedintheselectionandintheclinical treatment of the patients, had access to this list and was aware of the random sequence. The in- formationaboutthetreatmentofeachpatientwas contained in sealed envelopes, sequentiallynum- bered, identical and opaque. Envelopes were openedsequentially,afterosteotomypreparation andbeforeimplantinsertion.Treatmentallocation was concealed to the investigators in charge of enrolling and treating the patients. S u r g i c a l p r o c e d u r e All of the patients received prophylactic antibi- otictherapy(2 g ofamoxicillin or600 mg ofclin- damycinifallergictopenicillin1hpriortoimplant surgery). After local anesthesia (articaine with

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