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Completed

NCT Number: NCT05896319

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Delayed Wound Healing Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Tooth Extraction Status Nos

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.I.R Dental School, University of Turin

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyaluronic acid gel

Device

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".

Primary outcomes

  1. 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.

  2. 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

  1. Change in pain assessment

    Time frame: After 3, 7, 14, and 21 days from the extraction

    Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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