]>
IRCT2017021025662N2 IRCT 2017-06-11 Vice chancellor for research, Tehran University of Medical Sciences Evaluation of marginal bone level around short maxillary implants Evaluation of marginal bone level around bone-level and tissue-level short implants in posterior maxilla 2017-04-03 anticipated 16 Complete https://irct.ir/trial/21417 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Dental implant. Condition 2: Edentuous ridge atrophy. Intervention 1: Intervention group: Patients who meet inclusion criteria, after signing an informed consent enter the study. Surgery for implant placement: Patients rinse their mouth with chlorhexidine 2.2% mouthrinse. Local anesthesia is applied. Then, buccal flap is reflected and before reflecting palatal one, mucosal thickness of palatal tissue in center area of placing implant is measured and recorded. Now, an assistant opens the envelope which determines due to randomization, which type of implant should be inserted for the patient. Implant of Euroteknika brand are to be used in this study; test group will receive Aesthetica tissue-level implants. The length of implant chosen is 6 or 8 millimeters, depending on the available bone. Drilling and placing implant at desired level relative to bone crest is done according to manufacturer's instruction. One week later, after suture removal, a standardized parallel periapical radiograph is obtained from study implants. For this, a digital sensor, mounted on an XCP film holder- which is bound to a piece of putty material for registering the exact position of the sensor and tube relative to the implant- is used. The putty can then be used in two other radiographs to provide identical geometry as the first one. Three months after inserting implants, impression making begins and prosthesis is delivered. Type of prosthesis to be used is cemented porcelain-fused-to- metal crowns. At the time of prosthesis delivery, probing depth and bleeding on probing around implant, and full mouth plaque index are recorded, and a standardized radiograph, as described before, is taken. Six months later, PD, and BoP of the implant, and FMPI are recorded, and a standardized radiograph is taken For evaluation of marginal bone level, CBCT viewer software is used for assessing the radiographs. First, each radiograph is given a code by a blind person out of the study, then one of the investigators make measurements on the image. The measurements to be made are: 1-"Bone level": the distance between the most coronal point of implant-bone contact to the most coronal point of implant platform in either mesial and distal sides. 2- the distance between implant apex and its shoulder, which is used to calibrate other measurements of the graph. Differences in bone level between the radiographs is obtained after calibrating the measures [primary outcome]. Mean marginal bone loss for the test group -tissue level implants- is calculated and compared to the control's. Intervention 2: Control group: Patients who meet inclusion criteria, after signing an informed consent enter the study. Surgery for implant placement: Patients rinse their mouth with chlorhexidine 2.2% mouthrinse. Local anesthesia is applied. Then, buccal flap is reflected and before reflecting palatal one, mucosal thickness of palatal tissue in center area of placing implant is measured and recorded. Now, an assistant opens the envelope which determines due to randomization, which type of implant should be inserted for the patient. Implant of Euroteknika brand are to be used in this study; control group will receive Natea bone-level implants. The length of implant chosen is 6 or 8 millimeters, depending on the available bone. Drilling and placing implant at desired level relative to bone crest is done according to manufacturer's instruction. One week later, after suture removal, a standardized parallel periapical radiograph is obtained from study implants. For this, a digital sensor, mounted on an XCP film holder- which is bound to a piece of putty material for registering the exact position of the sensor and tube relative to the implant- is used. The putty can then be used in two other radiographs to provide identical geometry as the first one. Three months after inserting implants, impression making begins and prosthesis is delivered. Type of prosthesis to be used is cemented porcelain-fused-to- metal crowns. At the time of prosthesis delivery, probing depth and bleeding on probing around implant, and full mouth plaque index are recorded, and a standardized radiograph, as described before, is taken. Six months later, PD, and BoP of the implant, and FMPI are recorded, and a standardized radiograph is taken For evaluation of marginal bone level, CBCT viewer software is used for assessing the radiographs. First, each radiograph is given a code by a blind person out of the study, then one of the investigators make measurements on the image. The measurements to be made are: 1-"Bone level": the distance between the most coronal point of implant-bone contact to the most coronal point of implant platform in either mesial and distal sides. 2- the distance between implant apex and its shoulder, which is used to calibrate other measurements of the graph. Differences in bone level between the radiographs is obtained after calibrating the measures [primary outcome]. Mean marginal bone loss for the control group -bone level implants- is calculated and compared to the test's.
public Mina Taheri
Tehran university dental school, North Amirabaad, Tehran
Tehran Iran (Islamic Republic of) +98 21 8835 1170 mtaherim@gmail.com Department of periodontics, Tehran University of Medical Sciences, School of Dentistry scientific Soolmaz Akbari
Tehran university dental school, North Amirabaad, Tehran
Tehran Iran (Islamic Republic of) +98 21 8835 1170 soolmaz.akbari@gmail.com Department of periodontics, Tehran University of Medical Sciences, School of Dentistry Iran (Islamic Republic of) Inclusion criteria: Edentulous area of at least one tooth missed in the posterior sextant of maxilla; which is considered to be treated with implant supported fixed prosthesis; available bone height of at least 6 mm and less than 10 mm below the maxillary sinus in the area planned for implant insertion, as observed in CBCT radiograph; available bone width of at least 6 mm in the area planned for implant insertion as observed in CBCT radiograph; sinus augmentation not planned, because of medical reasons or patient's unwillingness; and patient's willing for cooperation with the study. Exclusion criteria: Active periodontal disease (Probing pocket depth >=4 mm with bleeding on probing); full mouth plaque score >20% at time of implant placement; full mouth bleeding score >20% at time of implant placement; smoking >10 cigarettes/day; systemic disease or conditions which influence bone metabolism; and bruxism or clenching. 18 years no limit Both Z96.5 K08.2 K00-K14Presence of tooth-root and mandibular implants Atrophy of edentulous alveolar ridge Treatment - Surgery Treatment - Drugs Intervention group: Patients who meet inclusion criteria, after signing an informed consent enter the study. Surgery for implant placement: Patients rinse their mouth with chlorhexidine 2.2% mouthrinse. Local anesthesia is applied. Then, buccal flap is reflected and before reflecting palatal one, mucosal thickness of palatal tissue in center area of placing implant is measured and recorded. Now, an assistant opens the envelope which determines due to randomization, which type of implant should be inserted for the patient. Implant of Euroteknika brand are to be used in this study; test group will receive Aesthetica tissue-level implants. The length of implant chosen is 6 or 8 millimeters, depending on the available bone. Drilling and placing implant at desired level relative to bone crest is done according to manufacturer's instruction. One week later, after suture removal, a standardized parallel periapical radiograph is obtained from study implants. For this, a digital sensor, mounted on an XCP film holder- which is bound to a piece of putty material for registering the exact position of the sensor and tube relative to the implant- is used. The putty can then be used in two other radiographs to provide identical geometry as the first one. Three months after inserting implants, impression making begins and prosthesis is delivered. Type of prosthesis to be used is cemented porcelain-fused-to- metal crowns. At the time of prosthesis delivery, probing depth and bleeding on probing around implant, and full mouth plaque index are recorded, and a standardized radiograph, as described before, is taken. Six months later, PD, and BoP of the implant, and FMPI are recorded, and a standardized radiograph is taken For evaluation of marginal bone level, CBCT viewer software is used for assessing the radiographs. First, each radiograph is given a code by a blind person out of the study, then one of the investigators make measurements on the image. The measurements to be made are: 1-"Bone level": the distance between the most coronal point of implant-bone contact to the most coronal point of implant platform in either mesial and distal sides. 2- the distance between implant apex and its shoulder, which is used to calibrate other measurements of the graph. Differences in bone level between the radiographs is obtained after calibrating the measures [primary outcome]. Mean marginal bone loss for the test group -tissue level implants- is calculated and compared to the control's. Control group: Patients who meet inclusion criteria, after signing an informed consent enter the study. Surgery for implant placement: Patients rinse their mouth with chlorhexidine 2.2% mouthrinse. Local anesthesia is applied. Then, buccal flap is reflected and before reflecting palatal one, mucosal thickness of palatal tissue in center area of placing implant is measured and recorded. Now, an assistant opens the envelope which determines due to randomization, which type of implant should be inserted for the patient. Implant of Euroteknika brand are to be used in this study; control group will receive Natea bone-level implants. The length of implant chosen is 6 or 8 millimeters, depending on the available bone. Drilling and placing implant at desired level relative to bone crest is done according to manufacturer's instruction. One week later, after suture removal, a standardized parallel periapical radiograph is obtained from study implants. For this, a digital sensor, mounted on an XCP film holder- which is bound to a piece of putty material for registering the exact position of the sensor and tube relative to the implant- is used. The putty can then be used in two other radiographs to provide identical geometry as the first one. Three months after inserting implants, impression making begins and prosthesis is delivered. Type of prosthesis to be used is cemented porcelain-fused-to- metal crowns. At the time of prosthesis delivery, probing depth and bleeding on probing around implant, and full mouth plaque index are recorded, and a standardized radiograph, as described before, is taken. Six months later, PD, and BoP of the implant, and FMPI are recorded, and a standardized radiograph is taken For evaluation of marginal bone level, CBCT viewer software is used for assessing the radiographs. First, each radiograph is given a code by a blind person out of the study, then one of the investigators make measurements on the image. The measurements to be made are: 1-"Bone level": the distance between the most coronal point of implant-bone contact to the most coronal point of implant platform in either mesial and distal sides. 2- the distance between implant apex and its shoulder, which is used to calibrate other measurements of the graph. Differences in bone level between the radiographs is obtained after calibrating the measures [primary outcome]. Mean marginal bone loss for the control group -bone level implants- is calculated and compared to the test's. Marginal bone level changes. Timepoint: At implant placement, prosthesis delivery and 6 months later. Method of measurement: a standardized radiograph is taken For evaluation of marginal bone level, CBCT viewer software is used for assessing the radiographs. the distance between bone to implant contact and platform of each implant, at mesial and distal of implants were calculated at each intervals. Probing depth. Timepoint: At prosthesis delivery and 6 months later. Method of measurement: O’ Michigan, Williams marking probe. Bleeding on probing. Timepoint: At prosthesis delivery and 6 months later. Method of measurement: Bleeding on probing with O’ Michigan, Williams marking, which may happen till 30 seconds later. Implant survival rate. Timepoint: At prosthesis delivery and 6 months later. Method of measurement: Percentage of remained implants in oral cavity at the end of study. --- --- Vice chancellor for research, Tehran University of Medical Sciences Approved 2017-03-25 Ethics Committee, Tehran University of Medical Sciences Keshavarz blvd, Ghods ave, Head quarter of Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)