Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
NCT ID: NCT05896319
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2022-09-07
2023-03-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The null hypothesis was that HA can significantly improve the post extractive healing of diabetic patients compared with no treatment.
36 patients with diabetes mellitus type 2 requiring bilateral extraction of the homologous, not included, teeth were enrolled. After the extractions carried out in the same appointment, following the split-mouth design of the study, one site was randomly assigned to the test (T) group, while the other one was assigned to the control group (C).
T group included: Post-operative application of Hyaluronic acid gels 3 times per day
C group included: no treatment.
Patients were then followed after 3, 7,14 and 21 days and the healing of each socket was evaluated and compared between the 2 groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Hyaluronic Acid and Single Dose Corticosteroid Injection to Improve Wound Healing in Controlled Diabetic Patients Post Tooth Extraction.
NCT06637384
Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction
NCT03428698
the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket
NCT05122299
The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain
NCT05776290
Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets
NCT07318298
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
Postoperative application of hyaluronic acid gels 3 times per day for 7 days after tooth extraction
Hyaluronic acid gel
Post-operative application of Hyaluronic acid gel 3 times per day (8 hours distance between each application) for 7 days after oral hygiene and without swallowing, eating or drinking for one hour after the application, as follows: "wash your hands thoroughly before each application, apply a layer of gel on the injured mucosa, massage with a finger in order to facilitate spreading of the product over the treated area".
Control group
No adjunctive therapy undergoing natural healing
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyaluronic acid gel
Post-operative application of Hyaluronic acid gel 3 times per day (8 hours distance between each application) for 7 days after oral hygiene and without swallowing, eating or drinking for one hour after the application, as follows: "wash your hands thoroughly before each application, apply a layer of gel on the injured mucosa, massage with a finger in order to facilitate spreading of the product over the treated area".
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diabetic type 2 patients with glycaemia levels under control but with a positive history for diabetes complications (e.g., nephropathy, neuropathy, retinopathy, cardiopathy, peripheral vascular disease)
* agreement to be enrolled in the study
* availability to come at the control visit
Exclusion Criteria
* presence of thrombocytopenia
* corticosteroid treatment
* smokers
* refusal to participate in the study
* assumption of drugs possibly interacting with the wound healing
* extractions requiring the elevation of a flap
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Massimo Carossa
Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
C.I.R Dental School, University of Turin
Turin, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yang S, Li Y, Liu C, Wu Y, Wan Z, Shen D. Pathogenesis and treatment of wound healing in patients with diabetes after tooth extraction. Front Endocrinol (Lausanne). 2022 Sep 23;13:949535. doi: 10.3389/fendo.2022.949535. eCollection 2022.
Marin S, Popovic-Pejicic S, Radosevic-Caric B, Trtic N, Tatic Z, Selakovic S. Hyaluronic acid treatment outcome on the post-extraction wound healing in patients with poorly controlled type 2 diabetes: A randomized controlled split-mouth study. Med Oral Patol Oral Cir Bucal. 2020 Mar 1;25(2):e154-e160. doi: 10.4317/medoral.23061.
Ibraheem W, Jedaiba WH, Alnami AM, Hussain Baiti LA, Ali Manqari SM, Bhati A, Almarghlani A, Assaggaf M. Efficacy of hyaluronic acid gel and spray in healing of extraction wound: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(10):3444-3449. doi: 10.26355/eurrev_202205_28838.
Kim JJ, Song HY, Ben Amara H, Kyung-Rim K, Koo KT. Hyaluronic Acid Improves Bone Formation in Extraction Sockets With Chronic Pathology: A Pilot Study in Dogs. J Periodontol. 2016 Jul;87(7):790-5. doi: 10.1902/jop.2016.150707. Epub 2016 Mar 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Unito-DM2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.