Diabetes Mellitus, Type 2NCT05896319
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
A study testing Hyaluronic acid gel in people with Diabetes Mellitus, Type 2 and Delayed Wound Healing, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Delayed Wound Healing, Tooth Extraction Status Nos
- What is being tested?
- Hyaluronic acid gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2022to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Being tested
- Hyaluronic acid gel
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelDevice
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".
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Postoperative application of hyaluronic acid gels 3 times per day for 7 days after tooth extraction Receives: Device: Hyaluronic acid gel |
| Control group | No intervention | No adjunctive therapy undergoing natural healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3, 7, 14, and 21 days from the extraction
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).
Measured: After 3, 7, 14, and 21 days from the extraction
Secondary outcomes (1)
Change in pain assessment
Visual Analogue Scale
Measured: After 3, 7, 14, and 21 days from the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start7 Sep 2022
- Primary completion8 Feb 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Carossa, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896319
- Sponsor's protocol ID
- Unito-DM2022
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36213270Marin 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.
PubMed 32040462Ibraheem 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.
PubMed 35647824Kim 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.
PubMed 26991484
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05896319
- Acronym / sponsor ID
- Unito-DM2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Hyaluronic acid gelPostoperative application of hyaluronic acid gels 3 times per day for 7 days after tooth extraction |
| Control group | No intervention | –No adjunctive therapy undergoing natural healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- presence of platelet dysfunction
- presence of thrombocytopenia
- corticosteroid treatment
- smokers
- refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid gelPost-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". | Device | Treatment group |
Primary outcome
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).
1 secondary outcome
Change in pain assessment
Time frame: After 3, 7, 14, and 21 days from the extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 36213270Yang 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.
- Background: PubMed 32040462Marin 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.
- Background: PubMed 35647824Ibraheem 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.
- Background: PubMed 26991484Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel in people with Diabetes Mellitus, Type 2 and Delayed Wound Healing, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in healing index (time frame: After 3, 7, 14, and 21 days from the extraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896319, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.