Extraction Socket HealingNCT06617221
Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment
A study testing Composite graft plug and Allograft in people with Extraction Socket Healing and Socket Preservation, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extraction Socket Healing, Socket Preservation, Alveolar Ridge Preservation
- What is being tested?
- Composite graft plug and Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease
- good oral hygiene
- healthy periodontium or at least at the extraction area.
Who cannot join
- smoking ≥10 cigarettes per day
- generalized periodontitis
- poor oral hygiene
- uncontrolled systemic diseases such as diabetes
- pregnancy
- history of anti-resorptive therapy such as bisphosphonate
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth.
The main question it aims to answer is:
Read more
Is this graft material able to maintain good bone volume and composition after extraction?
Researchers will compare this new graft to a well-studied graft material.
Participants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.
Read the detailed description
Alveolar ridge resorption after tooth extraction poses a substantial obstacle for subsequent implant placement, frequently necessitating ridge augmentation treatments. Alveolar ridge preservation (ARP) is intended to reduce these dimensional alterations. Various grafting materials have been used for ARP, with varying success rates in maintaining ridge dimensions. This study compares the clinical and radiological outcomes of a composite graft plug of bioactive resorbable calcium apatite crystals embedded in a collagen matrix to a typical allograft.
This randomized controlled clinical experiment comprised 26 people needing a single-rooted tooth extracted. They were divided into two groups: composite plug and allograft. Clinical measures of soft tissue were collected at baseline and four months after extraction using a stent with reference points. At baseline and four months after extraction, radiographic examinations were performed using cone beam computed tomography (CBCT).
- Being tested
- Composite graft plug, Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite graft plugBiological
after tooth extraction the socket was grafted with a composite graft plug
AllograftBiological
after tooth extraction the socket was grafted with allograft
| Study group | Role | What they receive |
|---|---|---|
| Composite graft plug | Experimental | composite graft plug was placed in the socket after extraction Receives: Biological: Composite graft plug |
| Allograft | Active comparator | allograft was placed in the socket after extraction Receives: Biological: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiographic ridge alterations
Using a standardized stent with reference points , the following horizontal clinical measurements were obtained before extraction through the stent holes: buccal soft tissue thickness at 4, 7, and 10 mm apical to the gingival margin and palatal or lingual soft tissue thickness at similar sites. Vertical measurements were obtained an incisal or occlusal hole to the buccal aspect of the ridge (inciso-buccal) and the palatal/ lingual aspect (inciso-palatal). Radiographic width of the alveolar ridge was measure at the same reference points.
theses measurements were taken at baseline (before extraction) and at 4 months after extraction and socket graft
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2021
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extraction Socket HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Abubakr Badahdah, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617221
- Sponsor's protocol ID
- REC 4350-444
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, Medical condition, gender
Publications
Jafarian J, Shahrabi-Farahani S, Ferreira CF, Stewart CW, Luepke P. Histological Evaluation of Alveolar Ridge Preservation Using Different Bone Grafts: Clinical Study Analysis Part II. J Oral Implantol. 2024 Jun 1;50(3):260-265. doi: 10.1563/aaid-joi-D-23-00060.
PubMed 38660739Jones K, Williams C, Yuan T, Digeorge-Foushee AM, Chambers Wilson R, Burton T, Hamlin N, Martinez L. Comparative in vitro study of commercially available products for alveolar ridge preservation. J Periodontol. 2022 Mar;93(3):403-411. doi: 10.1002/JPER.21-0087. Epub 2021 Jul 12.
PubMed 34114665
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment
- ClinicalTrials.gov ID
- NCT06617221
- Acronym / sponsor ID
- REC 4350-444
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth.
The main question it aims to answer is:
Is this graft material able to maintain good bone volume and composition after extraction?
Researchers will compare this new graft to a well-studied graft material.
Participants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.
Detailed description
Alveolar ridge resorption after tooth extraction poses a substantial obstacle for subsequent implant placement, frequently necessitating ridge augmentation treatments. Alveolar ridge preservation (ARP) is intended to reduce these dimensional alterations. Various grafting materials have been used for ARP, with varying success rates in maintaining ridge dimensions. This study compares the clinical and radiological outcomes of a composite graft plug of bioactive resorbable calcium apatite crystals embedded in a collagen matrix to a typical allograft.
This randomized controlled clinical experiment comprised 26 people needing a single-rooted tooth extracted. They were divided into two groups: composite plug and allograft. Clinical measures of soft tissue were collected at baseline and four months after extraction using a stent with reference points. At baseline and four months after extraction, radiographic examinations were performed using cone beam computed tomography (CBCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite graft plug | Experimental | Biological: Composite graft plugcomposite graft plug was placed in the socket after extraction |
| Allograft | Active comparator | Biological: Allograftallograft was placed in the socket after extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease
- good oral hygiene
- healthy periodontium or at least at the extraction area.
Key exclusion criteria (6 listed)
- smoking ≥10 cigarettes per day
- generalized periodontitis
- poor oral hygiene
- uncontrolled systemic diseases such as diabetes
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composite graft plugafter tooth extraction the socket was grafted with a composite graft plug | Biological | Composite graft plug |
| Allograftafter tooth extraction the socket was grafted with allograft | Biological | Allograft |
Primary outcome
clinical and radiographic ridge alterations
Time frame: four months
Using a standardized stent with reference points , the following horizontal clinical measurements were obtained before extraction through the stent holes: buccal soft tissue thickness at 4, 7, and 10 mm apical to the gingival margin and palatal or lingual soft tissue thickness at similar sites. Vertical measurements were obtained an incisal or occlusal hole to the buccal aspect of the ridge (inciso-buccal) and the palatal/ lingual aspect (inciso-palatal). Radiographic width of the alveolar ridge was measure at the same reference points. theses measurements were taken at baseline (before extraction) and at 4 months after extraction and socket graft
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 38660739Jafarian J, Shahrabi-Farahani S, Ferreira CF, Stewart CW, Luepke P. Histological Evaluation of Alveolar Ridge Preservation Using Different Bone Grafts: Clinical Study Analysis Part II. J Oral Implantol. 2024 Jun 1;50(3):260-265. doi: 10.1563/aaid-joi-D-23-00060.
- Results publication: PubMed 34114665Jones K, Williams C, Yuan T, Digeorge-Foushee AM, Chambers Wilson R, Burton T, Hamlin N, Martinez L. Comparative in vitro study of commercially available products for alveolar ridge preservation. J Periodontol. 2022 Mar;93(3):403-411. doi: 10.1002/JPER.21-0087. Epub 2021 Jul 12.
- Individual participant dataSharing planned: Yes. Age, Medical condition, gender
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite graft plug and Allograft in people with Extraction Socket Healing and Socket Preservation, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical and radiographic ridge alterations (time frame: four months). 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 NCT06617221, which also lists 2 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 1 Oct 2024.