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IRCT20211224053505N1 IRCT 2022-02-19 Shiraz University of Medical Sciences Title : Acellular dermal matrix loaded with zinc oxide nanoparticles as a new membrane in extraction socket preservation technique: a clinical and CBCT study Acellular dermal matrix loaded with zinc oxide nanoparticles as a new membrane in extraction socket preservation technique: a clinical and CBCT study 2022-02-14 anticipated 22 Complete https://irct.ir/trial/60858 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation in test and control groups will be randomly assigned to each patient by computer-generated random number table. The randomization codes will be stored in password-protected portable computers and enclosed in sequentially numbered, identical, opaque, sealed envelopes. The envelopes will be opened in numerical order after tooth extraction, Blinding description: This study is a double blind randomized clinical trial. Randomization and patient allocation to each group will be done by a third person not involved in the other parts of the research.The resident, involved in the project, will perform the ESP surgeries. All pre- and postoperative clinical assessments will be done by a single, masked examiner who is not the operating surgeon and is blind to the groups. Training and calibration for measuring of CBCT criteria are conducted prior to the study to ensure intra and inter examiner reproducibility of the measured outcomes. Radiolographic data will be measured by a radiologist specialist and the resident. The patients are also blind in relation to the groups. 3 Extraction Socket preservation. Intervention 1: Intervention group: test group: ZnO Nano Particles loaded Acellular Dermal Matrix, Human skin specimen will be obtained from abdominal plastic surgeries performed in Department of Plastic Surgery, Shiraz University of Medical Sciences. The tissue samples are kept in phosphate buffer saline (PBS: Sigma Aldrich, USA), while penicillin-streptomycin (Sigma Aldrich, USA) and fungisone (Sigma Aldrich, USA) are also added. The skin samples are cut into pieces using a sterile blade and the remained tissue is kept at -۲۰ºC until use. After ۳ times washing with PBS, subdermal fat tissue and hair are excised, NaCl, Triton X۱۰۰ and EDTA solution are used for removal of epidermis. The washing solution is identical using ۰.۵%Triton X۱۰۰ and ۱۰mMEDTA for ۲ times. The ADM, then is incorporated with Zno nanoparticles ۳%. Intervention 2: Control group: Acellular Dermal Matrix manufactored by Regen company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Farin Kiany Yazdi
Dental school, Ghasrdasht Street
Shiraz Iran (Islamic Republic of) 1587871956 +98 71 3626 3193 farinkiany@yahoo.com Shiraz University of Medical Sciences scientific Farin Kiany Yazdi
Dental school, Ghasrdasht Street
Shiraz Iran (Islamic Republic of) 1587871956 +98 71 3626 3193 farinkiany@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age ≥ ۱۸ years Adequate restorative space for implant-retained restoration Presence of all ۵ walls of the socket At least ۱۰ mm alveolar bone height without impingement on the maxillary sinus or mandibular canal Presence of one mesial and one distal tooth. 18 years no limit Both Presence of periodontal disease smoking History of systemic diseases that contraindicate oral surgery Long-term non-steroidal anti-inflammatory drug therapy Bisphosphonate therapy Pregnancy or lactation Absence of vestibular or lingual socket wall K05.6 Periodontal disease, unspecified Treatment - Surgery Treatment - Surgery Intervention group: test group: ZnO Nano Particles loaded Acellular Dermal Matrix, Human skin specimen will be obtained from abdominal plastic surgeries performed in Department of Plastic Surgery, Shiraz University of Medical Sciences. The tissue samples are kept in phosphate buffer saline (PBS: Sigma Aldrich, USA), while penicillin-streptomycin (Sigma Aldrich, USA) and fungisone (Sigma Aldrich, USA) are also added. The skin samples are cut into pieces using a sterile blade and the remained tissue is kept at -۲۰ºC until use. After ۳ times washing with PBS, subdermal fat tissue and hair are excised, NaCl, Triton X۱۰۰ and EDTA solution are used for removal of epidermis. The washing solution is identical using ۰.۵%Triton X۱۰۰ and ۱۰mMEDTA for ۲ times. The ADM, then is incorporated with Zno nanoparticles ۳%. Control group: Acellular Dermal Matrix manufactored by Regen company Clinical evaluation: After tooth extraction: 1.Vestibular bone thickness (VBT), is measured with a surgical caliper ۲ mm below the residual alveolar bone margin to the nearest ۰.۵ mm. Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by caliper and periodontal probe. Clinical evaluation: After tooth extraction: Ridge width (RW) is measured at the midfacial level of the buccal bone plate using a surgical caliper ۲ mm from the crest of the ridge to the nearest ۰.۵ mm. Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by caliper and periodontal probe. Clinical evaluation: After tooth extraction: The heights of the vestibular and lingual crest (HVC-HLC) is measured by using a periodontal probe to connect the midfacial CEJs of the adjacent teeth, then measuring the vertical distance from that reference line to the crest of bone on the midfacial and midlingual sides. Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by caliper and periodontal probe. Radiographic evaluation: Linear measurements are made on the CBCT images: The horizontal ridge width is calculated at three horizontal lines (۱ mm, ۳ mm, and ۵ mm apical to the most coronal aspect of the crest) perpendicular to a vertical reference line drawn in the center of the extraction socket and crossing its most apical point at baseline (HW-۱, HW-۳, HW-۵). Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by Cone Beam Computed Tomography (CBCT). Radiographic evaluation: Linear measurements are made on the CBCT images: The thickness of the buccal bone plate is measured only at baseline on the same levels apical to the lingual bone crest (BBP-۱, BBP-۳, BBP-۵). Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by Cone Beam Computed Tomography (CBCT). Radiographic evaluation: Linear measurements are made on the CBCT images: The height of the socket walls is calculated at the midbuccal (BH) and midlingual (LH). Timepoint: At the baseline before performing the extraction socket preservation technique and then after 4 months. Method of measurement: by Cone Beam Computed Tomography (CBCT). Shiraz University of Medical Sciences Approved 2021-11-03 Ethics committee of Shiraz University of Medical Sciences Dental school, Ghasrdasht Street, shiraz Fars Iran (Islamic Republic of)