Alveolar Ridge Preservation Using Sticky Bone and Chitosan
ConditionAlveolar Ridge Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDamascus University
About this trial
Alveolar ridge preservation (ARP) is commonly performed following tooth extraction to minimize post-extraction dimensional changes and maintain the alveolar ridge for subsequent implant placement. This study aims to clinically compare two grafting approaches for alveolar ridge preservation: a sticky bone consisting of bone graft mixed with platelet-rich fibrin (PRF), and bone graft combined with chitosan. The study will evaluate the effectiveness of these two approaches in preserving the dimensions and quality of the alveolar ridge following tooth extraction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years.
Systemically healthy or with mild systemic disease classified as ASA physical status I-II.
Clinical indication for extraction of two contralateral, symmetrical single-rooted teeth in the maxilla or mandible, with extraction not indicated because of periodontal disease.
Intact alveolar socket walls following extraction, including the buccal, lingual/palatal, mesial, and distal walls, confirmed clinically after extraction and supported by preoperative CBCT assessment.
Disqualifiers
Uncontrolled systemic diseases or conditions that may adversely affect bone metabolism or healing, including uncontrolled diabetes mellitus, hyperparathyroidism, or treatment with bisphosphonates, particularly intravenous administration.
Previous radiotherapy to the head and neck region.
Immunosuppression, including active chemotherapy or long-term treatment with high-dose systemic corticosteroids.
Pregnancy or breastfeeding.
Trial design
Design model
Crossover
Treatments tested in this trial
Sticky Bone (PRF Combined with Bone Graft)
Procedure/SurgeryFollowing atraumatic tooth extraction and standard socket preparation, autologous PRF will be prepared from the participant's venous blood and combined with the particulate bone graft to produce a cohesive sticky bone graft. The prepared graft mixture will then be placed into the designated extraction socket to provide alveolar ridge preservation during the healing period. Wound closure and postoperative management will be performed according to the standardized study protocol.
Chitosan Combined with Bone Graft
Procedure/SurgeryFollowing atraumatic tooth extraction and standard socket preparation, chitosan will be combined with the particulate bone graft to produce a homogeneous grafting material. The prepared mixture will then be placed into the designated extraction socket for alveolar ridge preservation during the healing period. Wound closure and postoperative management will be performed according to the standardized study protocol
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Sticky Bone (PRF Combined with Bone Graft)Active comparator 1 intervention
Group B: Chitosan Combined with Bone GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Alveolar Ridge Width
The change in alveolar ridge width will be assessed by comparing cone-beam computed tomography (CBCT) measurements obtained immediately after the surgical procedure (T1) with those obtained at 4 months postoperatively (T2). The corresponding CBCT images from T1 and T2 will be spatially matched using the OnDemand 3D imaging software to ensure standardized identification and measurement of the same anatomical levels at both time points. Alveolar ridge width will be measured at three standardized levels located 3 mm, 7 mm, and 10 mm apical to the cementoenamel junction (CEJ) of the tooth indicated for extraction. For each level, the change in ridge width will be calculated as the difference between the measurement at T1 and the corresponding measurement at T2. Alveolar ridge width and its change will be recorded in millimeters (mm).
Time frame
Immediately after the surgical procedure (T1) and at 4 months postoperatively (T2)Secondary outcomes
1
Change in Alveolar Ridge Height
The change in alveolar ridge height will be assessed using CBCT images obtained at T1 and T2. The corresponding images will be spatially matched using OnDemand 3D imaging software. Ridge height will be measured in millimeters (mm) at standardized reference locations, including the buccal plate and the midpoint of the extraction socket. The change in ridge height will be calculated as the difference between the T1 and T2 measurements.
Time frame
Immediately after the alveolar ridge preservation procedure (T1) and 4 months postoperatively (T2)2
Change in Bone Graft Volume
The volume of the grafted material within the extraction socket will be assessed using CBCT images acquired at T1 and T2. Three-dimensional volumetric measurements will be performed using OnDemand 3D imaging software by delineating the grafted area within the extraction socket. The change in graft volume will be calculated from the difference between the T1 and T2 measurements. Volume will be expressed in cubic millimeters (mm³).
Time frame
Immediately after graft placement (T1) and 4 months postoperatively (T2)3
Change in Bone Density at the Grafted Site
Bone density within the grafted extraction socket will be evaluated using CBCT images. A standardized region of interest within the grafted site will be assessed at both time points using OnDemand 3D imaging software. Bone density will be recorded in Hounsfield units (HU), and the change in bone density will be calculated as the difference between the T1 and T2 measurements.
Time frame
Immediately after graft placement (T1) and 4 months postoperatively (T2).4
Early Wound Healing
Early soft-tissue wound healing will be assessed clinically using the Landry Wound Healing Index. The index will be determined by clinical examination and standardized clinical photographs. The Landry index evaluates wound healing according to predefined clinical characteristics, with higher scores indicating better healing.
Time frame
Postoperative days 7,14,21,30 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: