Clinical trial NCT05896319: Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Delayed Wound Healing
Tooth Extraction Status Nos
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in healing index
timeFrame: After 3, 7, 14, and 21 days from the extraction
measure: Change in residual socket volume
timeFrame: After 3, 7, 14, and 21 days from the extraction
Secondary outcomes:
measure: Change in pain assessment
timeFrame: After 3, 7, 14, and 21 days from the extraction
Other outcomes:
Locations:
city: Turin
country: Italy
facility: C.I.R Dental School, University of Turin
Study officials:
References:
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.
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.
citation: 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.
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.