Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
- Conditions
- Diabetes Mellitus, Type 2Delayed Wound HealingTooth Extraction Status Nos
- Interventions
- Device: Hyaluronic acid gel
- Registration Number
- NCT05896319
- Lead Sponsor
- University of Turin, Italy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Hyaluronic acid gel Postoperative application of hyaluronic acid gels 3 times per day for 7 days after tooth extraction
- Primary Outcome Measures
Name Time Method Change in healing index After 3, 7, 14, and 21 days from the extraction 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.
Change in residual socket volume After 3, 7, 14, and 21 days from the extraction 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).
- Secondary Outcome Measures
Name Time Method Change in pain assessment After 3, 7, 14, and 21 days from the extraction Visual Analogue Scale
Trial Locations
- Locations (1)
C.I.R Dental School, University of Turin
🇮🇹Turin, Italy