Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Hyaluronic and Synthetic Amino Acids Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2: a Split-mouth Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896319
• Other study ID #: Unito-DM2022
• Status: Completed
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: May 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present split-mouth study was to investigate the effect of Hyaluronic Acid (HA) in improving the post-extraction tooth socket healing in subjects with diabetes mellitus type 2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18 years old
• 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 platelet dysfunction
• 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

Related Conditions & MeSH terms

• Delayed Wound Healing
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Tooth Extraction Status Nos

Intervention

Device:
• 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".

Locations

Country	Name	City	State
Italy	C.I.R Dental School, University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in healing index	3 possible scores for each of the 4 parameters considered: tissue color (1= 100% pink gum; 2=<50% hyperemic gum ; 3=>50% hyperemic gingiva), bleeding (1=absent; 2=provoked by palpation; 3=spontaneous), granulation tissue (1=pink and firm; 2=red and soft; 3=brittle), suppuration ( 1=no accumulation of plaque on the margins; 2=evident plaque on the margins; 3=suppuration/alveolitis). In this index, a score of 4 corresponds to excellent healing, conversely a score of 12 corresponds to very poor healing.	After 3, 7, 14, and 21 days from the extraction
Primary	Change in residual socket volume	Ratio between the volume of the healing socket at a given Time and the volume of the socket at T0. It was calculated by measuring (millimeters) the maximum oral-vestibule (OV) diameter, the maximum mesio-distal (MD) diameter, and the maximum socket depth (SD). MD diameter was measured in the point of the maximum MD width of the socket both for single-rooted and multi-rooted teeth. OV diameter was measured in the point of the maximum vestibule-oral width of the socket or of each root (considering only the maximum value for the pluri-rooted teeth). SD was measured as the distance between the gingival margin and the socket bone in the point of its maximum depth (without forcing the probe).	After 3, 7, 14, and 21 days from the extraction
Secondary	Change in pain assessment	Visual Analogue Scale	After 3, 7, 14, and 21 days from the extraction