Dry SocketNCT05536115

Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

An observational study of Dry Socket, run by Septodont at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket. ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket. Read more about this study

Who is it for?: Ages 5 years and older
Conditions the study is for: Dry Socket
What is being tested?: Alveogyl
Type of treatment: Medical device
How many people: 120 participants
Where: 16 sitesin 2 countries
Study dates: 13 Dec 2022to 26 Jun 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with a dry socket occuring after the extraction of a permanent tooth (mature or immature).

Who may be able to join

Male or female patient, adult or child
Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
Signed informed consent
In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")

Who cannot join

Spreading infection in the alveolar socket
Placement of Alveogyl done immediately after tooth extraction
Multiple post-extraction dry sockets
Patient treated with cervico-facial radiotherapy
Immunodeficiency related to any diseases or current treatments
Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS

Show all 9Show fewer

Patient with history of hypersensitivity to one of the components
Patient on post extraction of deciduous teeth
Participation in another clinical investigation

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

India14 sites

Mallige Hospital
Bangalore, Karnataka, 560001
Smile Dental Care
Bangalore, Karnataka, 560024
Perfect Dental Studio
Bangalore, Karnataka, 560076
Cavalier Hospital
Bangalore, Karnataka, 56009443
Smile Dental Clinic
Bangalore, Karnataka, 560094
The Dental Avenues
Bangalore, Karnataka, 560098
Sri Dental Multispeciality Dental Hospital
Hyderabad, 500070
Vrisa Dental
Hyderabad, 500079
Eledent International Digital Dentistry
Hyderabad, 500085
Vardhaman Dental Care
Mumbai, 421203
Mayur Dental Clinic
Mumbai, 421501
Smile Gallery Dental Care Center
Pune, 411004
Dr. Salke Dental & Implant Centre
Pune, 411016
Sri Siddhartha Dental College
Tumakuru, 572107

Other trials in India

France2 sites

Hospital Henri-Mondor (AP-HP)
Créteil, 94000
Odontology Department - Pitié-Salpêtrière Hospital
Paris, 75013

Other trials in France

About this study

Official title: Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.

ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.

The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .

Conditions: Dry Socket
Being tested: Alveogyl
Keywords: Tooth extraction, Dry socket, Alveolar Osteitis, Alveogyl, Surgical dressing
Medical subject headings: Dry Socket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlveogylDevice
The patients will be treated by Alveogyl. Global treatment protocol (curettage, cleaning, local anaesthesia etc.) of the dry socket is at the discretion of the Investigator.
Alveogyl is used as an alveolar dressing. Placement of Alveogyl (about 0.2 g of paste) into the dental socket is done according to its instruction for use by a dental professional only.

Study groups in NCT05536115
Study group	Role	What they receive
Study population		Study patients are patients with post-extraction dry socket. Receives: Device: Alveogyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Using a Visual Analog Scale (VAS : 0-10)
Patients with no pain or mild pain at Day7 The pain is measured by patients in a diary using a Visual Analogue Scale (VAS: 0-10 mm; 0 no pain - 10 maximum pain) 7 days after treatment with Alveogyl.
Measured: 7 days post-treatment

Secondary outcomes (6)

Analgesic Use
Patient reporting a painkiller intake. The patient will report in a diary the intake of analgesic use at 3 and 5 days after treatment with Alveogyl
Measured: 3 and 5 days post-treatment
Healing of the Alveolar Mucosa
Healing of the alveolar mucosa will be clinically reported by the dentist using le Wound healing index.
The Wound Healing Index ranges from 1 (poor healing) to 5 (excellent healing), with higher scores indicating better gingival wound healing.
Measured: 7 days post-treatment
Signs of Local Inflammation
Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment with Alveogyl
Measured: 7 days post-treatment
Antiseptic Effect
Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist
Measured: 7 days post-treatment
Hemostasis
Presence or absence of bleeding in the socket.
Measured: Immediately after Alveogyl placement and Day 7 after treatment
Complication Rate
Adverse events occuring within 7 days after treatment
Measured: From Alveogyl placement to 7 days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 202226 Jun 2025

First posted10 Sep 2022
Study start13 Dec 2022
Primary completion26 Jun 2025
Study completion26 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry SocketStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05536115
Sponsor's protocol ID: ALVE 2022-01
Other IDs: 2022-A00208-35, CI/MD/2022/66273
Status last verified: Apr 2026
First submitted: 7 Sep 2022
Last updated: 14 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
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Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
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PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
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All Dry Socket trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
ClinicalTrials.gov ID: NCT05536115
Acronym / sponsor ID: ALVE 2022-01
Conditions: Dry Socket
Keywords: Tooth extraction, Dry socket, Alveolar Osteitis, Alveogyl, Surgical dressing
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: SeptodontIndustry (pharma, biotech, devices)
Collaborators: SMO Clinical Research, QualityStat
Study start: 13 Dec 2022 (actual)
Primary completion: 26 Jun 2025 (actual)
Study completion: 26 Jun 2025 (actual)
First posted: 10 Sep 2022 (actual)
Results: Posted 9 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.

ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.

The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Study population	–	Device: AlveogylStudy patients are patients with post-extraction dry socket.

Who may qualify

Ages: 5 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with a dry socket occuring after the extraction of a permanent tooth (mature or immature).

Key inclusion criteria (4 listed)

Male or female patient, adult or child
Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
Signed informed consent
In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")

Key exclusion criteria (9 listed)

Spreading infection in the alveolar socket
Placement of Alveogyl done immediately after tooth extraction
Multiple post-extraction dry sockets
Patient treated with cervico-facial radiotherapy
Immunodeficiency related to any diseases or current treatments

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
AlveogylThe patients will be treated by Alveogyl. Global treatment protocol (curettage, cleaning, local anaesthesia etc.) of the dry socket is at the discretion of the Investigator. Alveogyl is used as an alveolar dressing. Placement of Alveogyl (about 0.2 g of paste) into the dental socket is done according to its instruction for use by a dental professional only.	Device	Study population

Primary outcome

Pain Using a Visual Analog Scale (VAS : 0-10)
Time frame: 7 days post-treatment
Patients with no pain or mild pain at Day7 The pain is measured by patients in a diary using a Visual Analogue Scale (VAS: 0-10 mm; 0 no pain - 10 maximum pain) 7 days after treatment with Alveogyl.

6 secondary outcomes

Analgesic Use
Time frame: 3 and 5 days post-treatment
Healing of the Alveolar Mucosa
Time frame: 7 days post-treatment
Signs of Local Inflammation
Time frame: 7 days post-treatment
Antiseptic Effect
Time frame: 7 days post-treatment
Hemostasis
Time frame: Immediately after Alveogyl placement and Day 7 after treatment
Complication Rate
Time frame: From Alveogyl placement to 7 days post-treatment

Results and safety

Results posted to the registry on 9 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Population	120	115

Primary outcome: Pain Using a Visual Analog Scale (VAS : 0-10)

Time frame: 7 days post-treatment. Count of participants. Unit: Participants

Measure	Study Population n = 110
Success : Patients with no pain or mild pain at Day7 (VAS<4)	106
Failure : Patients with moderate to severe pain at Day 7 (VAS ≥ 4)	4

Population analysed: PP Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Population	0 of 120 (0%)	0 of 120 (0%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Dry Socket

Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
RecruitingObservational study
PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
Pain, Dry Socket

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.

Géraldine Lescaille, DDS, PhD study director

Odontology department - Pitié-Salpêtrière Hospital

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Socket, run by Septodont at 16 sites in 2 countries.

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 9 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in India, France. 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?

Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Using a Visual Analog Scale (VAS : 0-10) (time frame: 7 days post-treatment). 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 NCT05536115.

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 14 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.