<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20241127063872N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation (Histological and Radiological examination):Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80521</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients do not know about control (Xenograft) and test (dentin graft).
In order to blind the surgery, the first stage (dentin graft and Xenograft placement) and the second stage (sample collection and implant placement) will be performed by two surgeons.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Candidate patients for implant placement in the posterior region of the maxilla and maxillary sinus floor augmentation surgery.</hc_freetext>
      <i_freetext>Intervention 1: **Intervention Group:**In the surgical procedure for the intervention group, 2 cc of allogenic demineralized dentin matrix is placed. Teeth with a poor prognosis (such as non-functioning third molars) and no root fillings are extracted. Soft tissue, debris, and cementum on the root surface are removed using a sickle scaler, and the pulp inside the root is extracted with a k-file; enamel is removed with a burr.The remaining dentin is rinsed with sterile saline and processed in a bone mill to create particles sized 1 to 1.5 mm. These particles are washed in a 0.1 M sodium chloride solution, treated with 0.1 M Tris-HCl (pH 7.4) for 10 minutes, and then demineralized in 2% HNO3 (pH 1.0).To acellularize the samples, trypsin, raffinose, and sucrose are used in Hanks buffer. Finally, the samples are washed three times with a PBS solution containing penicillin and streptomycin for 10 minutes each and then disinfected by UV. Intervention 2: Control group: In control surgery Xenograft (Bone +B; Nova Teb Pars, Marzanabad, Iran) is placed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the innovative nature of this research, the researchers have decided not to share the data. A final decision will be made after the data is collected.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Aghaziarati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar Soleimani Blvd</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665931</zip>
        <telephone>+98 41 3334 6977</telephone>
        <email>faa.ziarati2@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Aghaziarati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>faa.ziarati2@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The height of the remaining bone between the alveolar crest and the sinus floor 5mm or less
Presence of bilateral partial edentulism or complete edentulism in the posterior maxillary region</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pathological condition involving the sinus (cystic lesions , acute and chronic inflammatory disease and benign and malignant tumors)
Medical conditions known to affect bone metabolism such as osteoporosis
Drug regimen that affects the normal wound healing process ;Such as bisphosphonates and continuous use of corticosteroids
History of chemotherapy or head and neck Radiotherapy at the time of surgery or the next 6 months
Psychological problem that causes the patient's cooperation
Sinus membrane perforation during surgery
Smoking
Pregnant women
Systemic diseases such as uncontrolled diabetes and cardiovascular disease
Presence of untreated periodontal diseases and periapical lesions in the teeth adjacent to the sinus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>**Intervention Group:**In the surgical procedure for the intervention group, 2 cc of allogenic demineralized dentin matrix is placed. Teeth with a poor prognosis (such as non-functioning third molars) and no root fillings are extracted. Soft tissue, debris, and cementum on the root surface are removed using a sickle scaler, and the pulp inside the root is extracted with a k-file; enamel is removed with a burr.The remaining dentin is rinsed with sterile saline and processed in a bone mill to create particles sized 1 to 1.5 mm. These particles are washed in a 0.1 M sodium chloride solution, treated with 0.1 M Tris-HCl (pH 7.4) for 10 minutes, and then demineralized in 2% HNO3 (pH 1.0).To acellularize the samples, trypsin, raffinose, and sucrose are used in Hanks buffer. Finally, the samples are washed three times with a PBS solution containing penicillin and streptomycin for 10 minutes each and then disinfected by UV.</i_keyword>
      <i_keyword>Control group: In control surgery Xenograft (Bone +B; Nova Teb Pars, Marzanabad, Iran) is placed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of newly formed vital bone. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of newly formed vital bone is measured in square millimeters.</prim_outcome>
      <prim_outcome>Amount of remaining grafting material. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of the remaining graft material is measured in square millimeters.</prim_outcome>
      <prim_outcome>Bone density. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Based on the Hounsfield number From the CBCT by soft App Mimics 10.01.</prim_outcome>
      <prim_outcome>Bone height. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: The difference in bone height from the crest of the ridge to the bottom of the sinus between before surgery and 6 months after surgery in the patient's CBCT.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-18</approval_date>
        <contact_name>Ethics Committee in Biomedical Research Faculty of Dentistry Tabriz University of Medical Sciences</contact_name>
        <contact_address>TFaculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St, University St Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
