A comparative study of techniques for alveolar ridge preservation after tooth extraction

ISRCTN	ISRCTN92729767
DOI	https://doi.org/10.1186/ISRCTN92729767

Submission date: 17/09/2025
Registration date: 19/09/2025
Last edited: 19/09/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Tooth extraction often leads to bone loss in the alveolar ridge, which can affect future implant placement. This study compares two techniques for preserving the ridge using different bone graft materials.

Who can participate?
Adults aged 20–50 with two similar teeth requiring extraction.

What Does the Study Involve?
Participants will receive two different treatments on each side of the mouth. One side will be treated with Sticky Bone, and the other with a calcium sulfate/tricalcium phosphate mixture.

What are the possible benefits and risks of participating?
No benefits and risks provided at registration

Where is the study run from?
Faculty of Dentistry, Idlib University, Syria

When is the study starting and how long is it expected to run for?
December 2024 to May 2027

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Hussamdin Ismail, hussamdin_ismail@idlib.edu.sy

Contact information

Dr Hussam Ismail
Scientific, Principal Investigator

University Street
Idlib
+963
Syria

ORCID ID	0000-0001-7811-8648
Phone	+963 987733550
Email	dr.hussam.d.i@gmail.com

Prof Gohar Mushtaq
Public

Idlib University
Shoaib Street
Idlib
+44
Syria

ORCID ID	0000-0003-4880-4035
Phone	+963 7949825419
Email	gohar_mushtaq@idlib.edu.sy

Study information

Study design	Interventional randomized split-mouth single-centre non-blinded clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Dental clinic, University/medical school/dental school
Study type	Prevention, Treatment
Participant information sheet	48017_PIS.pdf
Scientific title	Effect of a mixture of calcium sulfate and tricalcium phosphate versus sticky bone technique on alveolar ridge preservation: a clinical, radiographic, and histological split-mouth study
Study acronym	ARP reserve
Study objectives	Evaluation of the efficacy of sticky bone graft and calcium sulfate in: Alveolar edge dimensions change Bone Density Osteogenesis (histological study)
Ethics approval(s)	Approved 15/05/2025, Ethics Committee of Idlib University (University Street, Idlib, -, Syria; +963936179302; fouad_aldaoud@idlib.edu.sy), ref: -
Health condition(s) or problem(s) studied	Alveolar ridge resorption following tooth extraction
Intervention	The method of randomization used in this study is allocation by the draw-a-card method. Group A (Sticky Bone): Atraumatic extraction followed by application of tricalcium phosphate mixed with PRF using the Sticky Bone technique. - Group B (CaSO₄ + TCP): Atraumatic extraction followed by application of a 40:60 mixture of calcium sulfate and tricalcium phosphate. - Follow-up Duration: 6 months - Measurements: Clinically: Measuring the dimensional changes of soft tissues and the thickness of the soft tissue covering the alveolar ridge crest. Radiographically: Evaluating the radiographic bone density of the newly formed bone and assessing the dimensional changes in the buccal and lingual walls of the socket. After standardizing the imaging parameters for cone-beam computed tomography (CBCT), radiographic scans will be taken using a Vatech X-ray device with the following settings: • 120 kVp, 5 mA • Voxel Size: 0.2 mm Two CBCT images will be taken: • First scan: Immediately after tooth extraction. • Second scan: Six months post-extraction. Both images will be loaded into the OnDemand3D software, where they will be aligned along the sagittal, coronal, and axial planes. The most relevant section of the image corresponding to the surgical intervention site will be selected. Histologically: Determining the quality of the newly formed bone six months after the surgical procedure. 1. Pain score using VAS at 1 and 7 days post-operative. 2. Healing index using the Landry scale at 1 week. 3. Soft tissue height at 6 months • Local anesthesia (2% lidocaine 1:100,000) administered to the alveolar ridge crest. A periodontal probe (UNC-15) will be inserted at the center of the soft tissue covering the alveolar ridge crest. A small drop of flowable composite will be placed on the soft tissue surface around the probe and then light-cured. The distance from the tip of the probe to the composite marker will be measured using a digital calliper.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Dimensional changes of soft tissues and the thickness of the soft tissue covering the alveolar ridge crest measured clinically after tooth extraction and six months post-extraction 2. Bone density of the newly formed bone and assessing the dimensional changes in the buccal and lingual walls of the socket, measured using cone-beam computed tomography (CBCT) with a Vatech X-ray device immediately after tooth extraction and six months post-extraction 3. Quality of the newly formed bone measured using histology six months after the surgical procedure
Secondary outcome measures	1. Pain measured using a Visual Analog Score (VAS) at 1 and 7 days post-operative 2. Healing measured using the Healing Index Landry scale at 7 days post-operative 3. Soft tissue height measured using the periodontal probe (UNC-15) method at 6 months
Overall study start date	08/12/2024
Completion date	20/05/2027

Eligibility

Participant type(s)	Patient, Service user
Age group	Adult
Lower age limit	20 Years
Upper age limit	50 Years
Sex	Both
Target number of participants	12 participants (24 extraction sites)
Total final enrolment	14
Key inclusion criteria	1. Age 20–50 years 2. Good oral hygiene 3. Presence of two similar teeth requiring extraction in the same jaw (both upper and lower jaw) 4. The patient has two symmetrical teeth indicated for extraction 5. Type 1 socket classification (Elian) (indicating that the buccal bone plate is intact and undamaged following tooth extraction)
Key exclusion criteria	1. Smokers or alcohol users 2. Systemic diseases or medications affecting bone healing 3. Pregnant or lactating women 4. Presence of infection or fistula at the extraction site
Date of first enrolment	16/06/2025
Date of final enrolment	21/12/2026

Locations

Countries of recruitment

Syria

Study participating centre

Faculty of Dentistry – Idlib University

University Street
Idlib
-
Syria

Sponsor information

Idlib University
University/education

University Street
Idlib
-
Syria

Phone	+963 179302
Email	info@idlib.edu.sy
Website	https://idlib.university
"ROR"	https://ror.org/038n03236

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	20/01/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hussamdin Ismail, hussamdin_ismail@idlib.edu.sy. The shared dataset will include anonymized variables such as pain scores, healing indices, soft tissue measurements, radiographic bone density, and histological findings. Data will be made available via an open-access repository such as Zenodo or Dryad, or upon reasonable request to the principal investigator. Access will be granted to qualified researchers who provide a clear research purpose, obtain ethical approval, and sign a data use agreement ensuring responsible and confidential use.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			19/09/2025	No	Yes
Protocol file			19/09/2025	No	No

Additional files

48017_Protocol.pdf
48017_PIS.pdf

Editorial Notes

19/09/2025: Study's existence confirmed by the Idlib University, University Council.