Alveolar Ridge Preservation
Conditions
Keywords
Alveolar Ridge Preservation, Tooth Extraction, Sticky Bone, Chitosan
Brief summary
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.
Detailed description
The present study is designed to clinically compare two approaches for alveolar ridge preservation following tooth extraction: a particulate bone graft combined with autologous advanced platelet-rich fibrin, forming a sticky bone graft, and the same particulate bone graft combined with chitosan. The study will use a split-mouth design, in which eligible patients requiring extraction of comparable teeth on both sides of the oral cavity will receive the two different interventions, with each side serving as a treatment site. Following atraumatic tooth extraction and standardized socket debridement, the extraction sockets will undergo alveolar ridge preservation using one of the two assigned grafting approaches. In the PRF site, autologous PRF will be prepared from venous blood and combined with the particulate bone graft. In the chitosan site, the same type of particulate bone graft will be combined with chitosan to obtain a homogeneous grafting mixture. The graft materials will then be placed within the extraction sockets according to the standardized surgical protocol, followed by wound closure and routine postoperative care.
Interventions
PROCEDURESticky Bone (PRF Combined with Bone Graft)
Following 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.
PROCEDUREChitosan Combined with Bone Graft
Following 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
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 65 years. 2. Systemically healthy or with mild systemic disease classified as ASA physical status I-II. 3. Clinical indication for extraction of two contralateral, symmetrical single-rooted teeth in the maxilla or mandible, with extraction not indicated because of periodontal disease. 4. 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. 5. A minimum width of 2 mm of keratinized tissue at each planned extraction site. 6. Good oral hygiene, defined as an O'Leary Plaque Control Record of less than 25%.
Exclusion criteria
1. 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. 2. Previous radiotherapy to the head and neck region. 3. Immunosuppression, including active chemotherapy or long-term treatment with high-dose systemic corticosteroids. 4. Pregnancy or breastfeeding. 5. Multirooted teeth, including molars or teeth with root furcation involvement. 6. Known allergy or hypersensitivity to bovine collagen, if a bovine-derived bone graft is used, or to chitosan or shellfish products such as shrimp. 7. Acute infection or a purulent abscess at the extraction site, or a large periapical lesion. 8. Presence of buccal bone dehiscence or fenestration at the planned extraction site. 9. Current smoking. 10. Untreated or inadequately controlled periodontal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Ridge Width | Immediately after the surgical procedure (T1) and at 4 months postoperatively (T2) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Ridge Height | Immediately after the alveolar ridge preservation procedure (T1) and 4 months postoperatively (T2) | 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. |
| Change in Bone Graft Volume | Immediately after graft placement (T1) and 4 months postoperatively (T2) | 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). |
| Change in Bone Density at the Grafted Site | Immediately after graft placement (T1) and 4 months postoperatively (T2). | 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. |
| Early Wound Healing | Postoperative days 7,14,21,30 days | 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. |
| Postoperative Complications | Postoperative days 3, 7, and 14 | Postoperative complications will be assessed clinically during scheduled follow-up visits. The presence or absence of the following complications will be recorded for each treatment site: infection, graft exposure, flap necrosis, wound dehiscence, and severe edema. Each complication will be recorded as a binary outcome (Yes/No) based on clinical examination. The occurrence of any complication will also be documented in the study record. |
| Postoperative Pain | During the first 7 postoperative days | Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will record their pain level during the first postoperative week using a 100-mm VAS, where 0 = no pain and 100 = worst imaginable pain. Pain scores will be recorded for each treatment site according to the study assessment schedule. |
| Postoperative Analgesic Consumption | During the first 7 postoperative days | Analgesic consumption will be assessed by recording the number of analgesic tablets taken by each participant during the first postoperative week. Participants will record analgesic use in a postoperative diary, and the total number of tablets consumed during the 7-day period will be recorded as a count (number of tablets). |
| Postoperative Bleeding | During the first 7 postoperative days | Postoperative bleeding will be assessed based on participant-reported bleeding during the first postoperative week and documented in the postoperative follow-up record. Bleeding will be recorded as present or absent (Yes/No) for each treatment site. Any clinically significant bleeding episode requiring additional intervention will also be documented. |
| Postoperative Edema | Postoperative days 3, 5, and 7 | Postoperative facial edema will be assessed clinically during follow-up visits. The presence and severity of edema will be recorded using a standardized clinical assessment. Edema will be categorized as absent, mild, moderate, or severe based on clinical examination and comparison with the preoperative condition. |
| Duration of Impairment of Daily Activities | During the first 14 postoperative days | The duration for which postoperative symptoms affect the participant's normal daily activities will be assessed using a postoperative patient diary. Participants will record the number of days during which their daily activities were partially or completely impaired because of the surgical procedure. The outcome will be expressed as the number of affected days |
| Patient Satisfaction with Treatment at Each Extraction Site | 4 months postoperatively | Patient satisfaction with the treatment received at each extraction site will be assessed using a Visual Analog Scale (VAS) at 4 months after the procedure. Participants will rate their satisfaction on a 100-ةm VAS ranging from 0 = completely dissatisfied to 100 = completely satisfied. Satisfaction will be recorded separately for each treatment site. |
| Change in Oral Health-Related Quality of Life | Baseline and 4 months postoperatively | Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The OHIP-14 consists of 14 items evaluating the impact of oral conditions on daily life. Each item is scored on a five-point response scale from 0 = never to 4 = very often, with total scores ranging from 0 to 56. A lower total score indicates better oral health-related quality of life. The change in OHIP-14 score from baseline to 4 months will be assessed. |
| Feasibility of Dental Implant Placement | 4 months postoperatively | The feasibility of dental implant placement at each preserved extraction site will be assessed clinically and radiographically at the 4-month follow-up. The site will be considered suitable for implant placement when the available ridge width is sufficient to accommodate a dental implant with a diameter of at least 3.5 mm, according to the predefined surgical criteria. The outcome will be recorded as feasible or not feasible (Yes/No). |
| Need for Additional Bone Augmentation Before Implant Placement | 4 months postoperatively, before implant placement | The need for additional bone augmentation before dental implant placement will be assessed clinically and radiographically at the 4-month follow-up. Each treatment site will be classified according to whether additional augmentation is required to achieve adequate hard-tissue dimensions for implant placement. The outcome will be recorded as Yes/No, indicating whether additional bone augmentation is required. |
| Width of Keratinized Tissue | 4 months postoperatively | The width of keratinized tissue at each treated extraction site will be measured clinically using a periodontal probe. The measurement will be taken from the gingival margin to the mucogingival junction at the designated treatment site. The width of keratinized tissue will be recorded in millimeters (mm). |
| Willingness to Undergo a Second Surgical Procedure | 4 months postoperatively | The participant's willingness to undergo a second surgical procedure at each treatment site will be assessed by direct questioning during the follow-up visit before the planned implant-related procedure. The response will be recorded separately for each treatment site as Yes or No |
Contacts
CONTACTWafeek Mansour, DDS, MSc student
CONTACTMohammed Monzer Alsabbagh, DDS, MSc, PhD
Outcome results
None listed