Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
ConditionAlveolar Bone Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-35
SponsorHorus University
About this trial
This study is designed to evaluate and compare clinically and radiographically the effectiveness of Demineralized Dentin Allograft (DDA) versus Demineralized Dentin Autograft (Auto-DD) for preservation of alveolar ridge dimensions after surgical extraction of the impacted mandibular third molar.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged between 25 to 35 years old.
Patients scored as (ASA I).
No adverse habits such as smoking, tobacco chewing, alcohol.
Patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (Kim JY, et al).
Disqualifiers
1) Pregnant or lactating patients. 2) Relevant systemic diseases. 3) Patients with history of chemotherapy or radiotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Demineralized Dentin Allograft
Procedure/Surgery20 sockets are randomly allocated to receive the Demineralized Dentin Allograft (split-mouth study)
Demineralized Dentin Autograft
Procedure/Surgery20 sockets are randomly allocated to receive the Demineralized Dentin Autograft (split-mouth study)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measuring and comparing the height of bone between the two groups
We will measure the height of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation
Time frame
Immediately post-operative, 3months post-operative, 6months post-operative2
Measuring and comparing the width of bone between the two groups
We will measure the width of the alveolar ridge clinically by using ridge mapping caliper (special caliper forceps used for measuring ridge dimensions) and radiographically on the cone-beam computed tomography (CBCT) and comparing the results of the study group (20 sockets) with the control group (the other 20sockets), to assess the effectiveness of Demineralized Dentin Allograft for ridge preservation
Time frame
Immediately post-operative, 3months post-operative, 6months post-operativeSecondary outcomes
1
Assess and comparing the mouth opening of both groups
Assess the mouth opening of the patient using a millimeter ruler (by measuring the distance between maxillary incisal edge and mandibular incisal edge) and comparing the results of both groups
Time frame
One day post-operative, one week post-operative2
Assess and comparing the swelling of both groups
Swelling levels after surgery will be measured using anatomic landmarks (Tragus-Labial commissure and Tragus-Pogonion), the distances between the landmarks used for the evaluation methods will be measured before the operation. All measurements will be done using millimeter ruler, while the patient will be seated.
Time frame
One day post-operative, one week post-operative3
Assess and comparing the pain of both groups
we will use the Visual Analogue Scale (VAS) for pain measurement
Time frame
One day post-operative, one week post-operative4
Assess and comparing the soft tissue parameters (bleeding on probing and color of the gingiva) of both groups
The bleeding on probing will be assessed by using periodontal probe and this will be done around mandibular first and second molars
Time frame
One day post-operative, one week post-operativeSponsors and contacts
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Source ClinicalTrials.gov