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Alveolar Ridge PreservationNCT07826377

Alveolar Ridge Preservation Using Sticky Bone and Chitosan

A study testing Sticky Bone (PRF Combined with Bone Graft) and Chitosan Combined with Bone Graft in people with Alveolar Ridge Preservation, run by Damascus University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alveolar Ridge Preservation
What is being tested?
Sticky Bone (PRF Combined with Bone Graft) and Chitosan Combined with Bone Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
4 Oct 2026to 4 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • A minimum width of 2 mm of keratinized tissue at each planned extraction site.
  • Good oral hygiene, defined as an O'Leary Plaque Control Record of less than 25%.

Who cannot join

  • 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.
  • Multirooted teeth, including molars or teeth with root furcation involvement.
  • Known allergy or hypersensitivity to bovine collagen, if a bovine-derived bone graft is used, or to chitosan or shellfish products such as shrimp.
Show all 10Show fewer
  • Acute infection or a purulent abscess at the extraction site, or a large periapical lesion.
  • Presence of buccal bone dehiscence or fenestration at the planned extraction site.
  • Current smoking.
  • Untreated or inadequately controlled periodontal disease.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wafeek Mansour, DDS, MSc student contact

+963 932 968 704

wafeekmansour89@gmail.com

Mohammed Monzer Alsabbagh, DDS, MSc, PhD contact

+963 945 626 810

momonzeralsabbagh@gmail.com

About this study

Official title: Comparison of Sticky Bone and Chitosan-Based Grafting for Alveolar Ridge Preservation Following Tooth Extraction

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.

Read the 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.

Being tested
Sticky Bone (PRF Combined with Bone Graft), Chitosan Combined with Bone Graft
Keywords
Alveolar Ridge Preservation, Tooth Extraction, Sticky Bone, Chitosan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sticky Bone (PRF Combined with Bone Graft)Procedure or surgery

    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.

  • Chitosan Combined with Bone GraftProcedure or surgery

    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

Study groups in NCT07826377
Study groupRoleWhat they receive
Sticky Bone (PRF Combined with Bone Graft)Active comparatorThis arm will receive a particulate bone graft combined with autologous advanced platelet-rich fibrin, forming a cohesive sticky bone graft, for alveolar ridge preservation following tooth extraction. This intervention will be applied to one eligible extraction site in each participant.
Receives: Procedure: Sticky Bone (PRF Combined with Bone Graft)
Chitosan Combined with Bone GraftExperimentalThis arm will receive the same particulate bone graft combined with chitosan for alveolar ridge preservation following tooth extraction. This intervention will be applied to the contralateral eligible extraction site in each participant
Receives: Procedure: Chitosan Combined with Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Immediately after the surgical procedure (T1) and at 4 months postoperatively (T2)

Secondary outcomes (16)
  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Postoperative days 7,14,21,30 days

  5. Postoperative Complications

    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.

    Measured: Postoperative days 3, 7, and 14

  6. Postoperative Pain

    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.

    Measured: During the first 7 postoperative days

  7. Postoperative Analgesic Consumption

    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).

    Measured: During the first 7 postoperative days

  8. Postoperative Bleeding

    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.

    Measured: During the first 7 postoperative days

  9. Postoperative Edema

    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.

    Measured: Postoperative days 3, 5, and 7

  10. Duration of Impairment of Daily Activities

    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

    Measured: During the first 14 postoperative days

  11. Patient Satisfaction with Treatment at Each Extraction Site

    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.

    Measured: 4 months postoperatively

  12. Change in Oral Health-Related Quality of Life

    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.

    Measured: Baseline and 4 months postoperatively

  13. Feasibility of Dental Implant Placement

    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).

    Measured: 4 months postoperatively

  14. Need for Additional Bone Augmentation 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.

    Measured: 4 months postoperatively, before implant placement

  15. Width of Keratinized Tissue

    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).

    Measured: 4 months postoperatively

  16. Willingness to Undergo a Second Surgical Procedure

    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

    Measured: 4 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start4 Oct 2026 (estimated)
  3. Primary completion2 May 2027 (estimated)
  4. Study completion4 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07826377
Sponsor's protocol ID
UDDS-Perio-09-2026
Status last verified
Sep 2026
First submitted
13 Sep 2026
Last updated
17 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Siawasch SAM, Yu J, Castro AB, Dhondt R, Teughels W, Temmerman A, Quirynen M. Autologous platelet concentrates in alveolar ridge preservation: A systematic review with meta-analyses. Periodontol 2000. 2025 Feb;97(1):104-130. doi: 10.1111/prd.12609. Epub 2024 Sep 30.

    PubMed 39345008
  • Aldommari EA, Omair A, Qasem T. Titanium-prepared platelet-rich fibrin enhances alveolar ridge preservation: a randomized controlled clinical and radiographic study. Sci Rep. 2025 Jul 5;15(1):24065. doi: 10.1038/s41598-025-09528-4.

    PubMed 40617944
  • Al-Madhagy G, Darwich K, Alghoraibi I, Al-Moraissi EA. Radiographic evaluation of alveolar ridge preservation using a chitosan/polyvinyl alcohol nanofibrous matrix: A randomized clinical study. J Craniomaxillofac Surg. 2023 Dec;51(12):772-779. doi: 10.1016/j.jcms.2023.09.020. Epub 2023 Oct 12.

    PubMed 37863731
  • Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.

    PubMed 30623987
  • Pan J, Xu Q, Hou J, Wu Y, Liu Y, Li R, Pan Y, Zhang D. Effect of platelet-rich fibrin on alveolar ridge preservation: A systematic review. J Am Dent Assoc. 2019 Sep;150(9):766-778. doi: 10.1016/j.adaj.2019.04.025.

    PubMed 31439204

Questions about this trial

What is this clinical trial studying?

A study testing Sticky Bone (PRF Combined with Bone Graft) and Chitosan Combined with Bone Graft in people with Alveolar Ridge Preservation, run by Damascus University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wafeek Mansour, DDS, MSc student (+963 932 968 704, wafeekmansour89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alveolar Ridge Width (time frame: Immediately after the surgical procedure (T1) and at 4 months postoperatively (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07826377, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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Clinical Trial NCT07826377 | AzTrials