Hyaluronic and Synthetic Amino Acids Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2: a Split-mouth Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Change in healing index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •refusal to participate in the study
- •assumption of drugs possibly interacting with the wound healing
- •extractions requiring the elevation of a flap
Outcomes
Primary Outcomes
Change in healing index
Time Frame: 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
Time Frame: 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 Outcomes
- Change in pain assessment(After 3, 7, 14, and 21 days from the extraction)
Investigators
Massimo Carossa
Doctor
University of Turin, Italy