Evidence map›Paper›PMID 39028555›Full record

ArticleJMIR research protocols2024

Feasibility and Preliminary Efficacy of α-Calcium Sulfate Hemihydrate in Socket Preservation: Protocol for a Pilot Randomized Controlled Trial.

Muhammad Ruslin, Nurlindah Hamrun, Andi Tajrin, Andi Sitti Hajrah Yusuf, Rifaat Nurrahma, Diandra Sabrina Natsir-Kalla, Yossy Yoanita Ariestiana, Mukhtar Nur Anam, Chung-Ming Liu, Keng-Liang Ou

Abstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Muhammad RuslinDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0003-0943-4000
Nurlindah HamrunDepartment of Oral Biology, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0001-9319-0656
Andi TajrinDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0002-4186-7968
Andi Sitti Hajrah YusufDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0003-3010-4524
Rifaat NurrahmaDepartment of Prosthodontic, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0003-4356-2022
Diandra Sabrina Natsir-KallaDepartment of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.ORCID 0000-0002-8274-3486
Yossy Yoanita AriestianaDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0003-4165-103X
Mukhtar Nur AnamDepartment of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.ORCID 0000-0003-1933-9066
Chung-Ming LiuDepartment of Biomedical Engineering, College of Biomedical Engineering, China Medical University, Taichung, Taiwan.ORCID 0009-0006-1274-0040
Keng-Liang OuGraduate Institute of Dental Science, College of Dentistry, China Medical University, Taichung, Taiwan.ORCID 0000-0003-1786-6305

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTooth extraction procedures often lead to bone resorption, which can have adverse effects on the dimensions of the alveolar ridge. Research has shown that socket preservation techniques using bone graft substitutes can effectively minimize early bone loss in such cases. α-calcium sulfate hemihydrate (α-CSH) has garnered significant attention as a potential bone graft material due to its favorable properties, including osteoconductivity, angiogenic potential, and biocompatibility. Considering these facts, we developed a preliminary protocol for applying α-CSH in addressing alveolar bone loss following tooth extraction.

objectiveThis research's general objective is to evaluate the feasibility and initial effectiveness of α-CSH as bone-inducing graft material for socket preservation after tooth extraction.

methodsThis preliminary clinical trial will involve 30 fresh extraction sockets from individuals aged 18-35 years. The participants will be divided into 2 groups: one group will receive α-CSH graft material after tooth extraction for socket preservation, while the other group will not receive any graft material. Throughout the study, the participants will be closely monitored for safety measures, which will include clinical examinations, radiographic imaging, and blood tests. Radiographic imaging will be used extensively to assist the progress of bone formation.

resultsThe study commenced enrollment in August 2022 and is scheduled to conclude post assessments and analyses by the end of 2023. The results of the study are anticipated to be accessible in late 2024.

conclusionsThis clinical study represents the initial investigation in humans to assess the feasibility and efficacy of α-CSH in alveolar bone regeneration. We hypothesize that the inclusion of α-CSH can greatly expedite the process of bone formation within fresh sockets, resulting in a swift restoration of bone height without the disadvantages associated with harvesting autogenous bone graft.

trial registrationIndonesia Registry Center INA-D02FAHP; https://tinyurl.com/2jnf6n3s. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49922.

Indexed as

Calcium SulfateFeasibility StudiesTooth ExtractionTooth SocketAdolescentAdultAlveolar Bone LossBone SubstitutesFemaleHumansMalePilot ProjectsRandomized Controlled Trials as TopicYoung AdultBone SubstitutesCalcium Sulfatealveolar bonebonebone graftbone lossbone regenerationbone resorptiondentaldentistdentistryefficacyfeasibilitygraftimpacted toothpilotradiographic imagingregenerationsocket preservationtooth extractionα–calcium sulfate hemihydrateα-CSH

Identifiers

PMID39028555
PMCPMC11297378

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.