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IRCT20190626044018N1 IRCT 2020-01-11 Tehran University of Medical Sciences Effectiveness of filling the gap around immediate implants Dimensional changes of periimplant soft and hard tissues after immediate flapless implantition in posterior sites of the jaws, with or without filling the gap around implant; A randomised clinical trial 2019-11-11 anticipated 66 Complete https://irct.ir/trial/43255 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Blocked randomization with randomly selected block sizes Randomization unit: Individual Randomization sequence generation: Online www.graphpad.com/quickcalcs/randomize1 Allocation concealment: Type of intervention will be written on a paper and secured in a sealed enveloped for each patient. During the surgery and after implant placement the envelope will be opened and the type of intervention will be revealed, Blinding description: In this study, blinding the surgeon and the one who measures the outcomes will not be possible; but, the patient and the one who analyses the data will be blinded. N/A Dimensional changes of hard and soft tissues after tooth extraction. Intervention 1: Intervention group: After chlorhexidine mouthwash prescription and anesthesia with lidocaine molar teeth will be sectioned into crown and roots by high-speed bur and extracted by periotome and forceps atraumatically. Drilling will be performed sequentially into the interradicular bone without raising the flap. Implants will be inserted 1mm subcrestally. The gap around implants will be filled by xenograft. Healing abutments will be inserted and the socket will be sutured by a nonresorbable material. Intervention 2: Control group: Intervention group: After chlorhexidine mouthwash prescription and anesthesia with lidocaine molar teeth will be sectioned into crown and roots by high-speed bur and extracted by periotome and forceps atraumatically. Drilling will be performed sequentially into the interradicular bone without raising the flap. Implants will be inserted 1mm subcrestally. The gap around implants will be left empty. Healing abutments will be inserted the socket will be sutured by a nonresorbable material. Yes - There is a plan to make this available What will be shared: The whole IPD, study protocol, informed consent form and trial results will be published in the post-graduate thesis print. When: Unlimited access to the data since dissertation publish. To whom: There is no limit for IPD request Conditions: There is no specific requirement for researchers who need IPD Where to obtain: IPD requests should be sent by e-mail to Dr.Ali Homayouni: homayouni.dmd@gmail.com How to obtain: After sending the IPD request including the reason why you need the IPD, you will be qualified and the data will be sent within a month. Comments:
public Ali Homayouni
No. 29, East Akhlaghi St., Kolahdouz Ave.
Tehran Iran (Islamic Republic of) 1939844731 +98 21 2254 3982 homayouni.dmd@gmail.com Tehran University of Medical Sciences scientific Ali Homayouni
No. 29, East Akhlaghi St., Kolahdouz Ave.
Tehran Iran (Islamic Republic of) 1939844731 +98 21 2254 3982 homayouni.dmd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Presence of at least 1 molar tooth to be extracted and replaced by implant Presence of at least 3mm bone apical to the tooth 18 years no limit Both Uncontrolled Periodontitis Uncontrolled Diabetes Mellitus Patients smoking more than 10 cigarettes per day Presence of acute infection around the candidate tooth Treatment - Surgery Treatment - Surgery Intervention group: After chlorhexidine mouthwash prescription and anesthesia with lidocaine molar teeth will be sectioned into crown and roots by high-speed bur and extracted by periotome and forceps atraumatically. Drilling will be performed sequentially into the interradicular bone without raising the flap. Implants will be inserted 1mm subcrestally. The gap around implants will be filled by xenograft. Healing abutments will be inserted and the socket will be sutured by a nonresorbable material. Control group: Intervention group: After chlorhexidine mouthwash prescription and anesthesia with lidocaine molar teeth will be sectioned into crown and roots by high-speed bur and extracted by periotome and forceps atraumatically. Drilling will be performed sequentially into the interradicular bone without raising the flap. Implants will be inserted 1mm subcrestally. The gap around implants will be left empty. Healing abutments will be inserted the socket will be sutured by a nonresorbable material. Alveolar bone width changes. Timepoint: Preoperative and 6-month postoperative. Method of measurement: Cone Beam Computed Tomography. Alveolar bone height changes. Timepoint: Preoperative and 6-month postoperative. Method of measurement: Cone Beam Computed Tomography. Soft tissue height changes. Timepoint: Preoperative and 6-month postoperative. Method of measurement: Intra-oral scanner. Soft tissue thickness changes. Timepoint: Preoperative and 6-month postoperative. Method of measurement: Intra-oral scanner. Tehran University of Medical Sciences Approved 2019-10-22 Ethics committee of Tehran University of Medical Sciences School of Dentistry, North Kargar St. Tehran Tehran Iran (Islamic Republic of)