ClinicalTrials.gg
CompletedNCT05536115Updated May 14, 2026Results posted

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

An observational study in Dry Socket, sponsored by Septodont. Completed at 16 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Septodont · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
5 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Dry Socket

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Keywords

  • Tooth extraction
  • Dry socket
  • Alveolar Osteitis
  • Alveogyl
  • Surgical dressing
03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

Browse Dry Socket studies →

Lead sponsor

Septodont is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patient with history of to one of the components
  • Patient on post extraction of deciduous teeth
  • Participation in another clinical investigation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Study population

    Study patients are patients with post-extraction dry socket.

    Device: Alveogyl

Interventions

  • DeviceAlveogyl

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days post-treatment

Secondary outcomes

  1. 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

    Time frame: 3 and 5 days post-treatment

  2. 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.

    Time frame: 7 days post-treatment

  3. 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

    Time frame: 7 days post-treatment

  4. Antiseptic Effect

    Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist

    Time frame: 7 days post-treatment

  5. Hemostasis

    Presence or absence of bleeding in the socket.

    Time frame: Immediately after Alveogyl placement and Day 7 after treatment

  6. Complication Rate

    Adverse events occuring within 7 days after treatment

    Time frame: From Alveogyl placement to 7 days post-treatment

07

Results

Posted Feb 9, 2026

Participant flow

Participant flow — Overall Study
MilestoneStudy Population
Started120
Completed115
Not completed5

Outcome measures

PrimaryPain 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.

Time frame:
7 days post-treatment
Reported as:
Count of participants · Participants
Pain Using a Visual Analog Scale (VAS : 0-10)
ParticipantsStudy Population
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
SecondaryAnalgesic 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

Time frame:
3 and 5 days post-treatment
Reported as:
Count of participants · Participants
Analgesic Use
ParticipantsPP Population
Patient reporting a painkiller intake at 3 days after treatment with Alveogyl — Patient reporting a painkiller intake63
Patient reporting a painkiller intake at 3 days after treatment with Alveogyl — Patient not reporting a painkiller intake47
Patients reporting a painkiller intake at 5 days after treatment with Alveogyl — Patient reporting a painkiller intake20
Patients reporting a painkiller intake at 5 days after treatment with Alveogyl — Patient not reporting a painkiller intake90
SecondaryHealing 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.

Time frame:
7 days post-treatment
Reported as:
Mean · Wound healing index Score
Healing of the Alveolar Mucosa
Wound healing index ScoreStudy Population
Healing of the Alveolar Mucosa4.0 ± 0.8
SecondarySigns 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

Time frame:
7 days post-treatment
Reported as:
Count of participants · Participants
Signs of Local Inflammation
ParticipantsStudy Population
patients showing signs of inflammation around the gingival mucosa19
patients without signs of inflammation around the gingival mucosa91
SecondaryAntiseptic Effect

Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist

Time frame:
7 days post-treatment
Reported as:
Count of participants · Participants
Antiseptic Effect
ParticipantsStudy Population
Halitosis / bad breath — Yes12
Halitosis / bad breath — No96
Halitosis / bad breath — Unknown2
Fever — Yes2
Fever — No108
Fever — Unknown0
Tenderness of the gingival mucosa — Yes24
Tenderness of the gingival mucosa — No86
Tenderness of the gingival mucosa — Unknown0
Purulent collection in the alveolus and gingival mucosa — Yes0
Purulent collection in the alveolus and gingival mucosa — No110
Purulent collection in the alveolus and gingival mucosa — Unknown0
Pale discoloration of the dry socket — Yes17
Pale discoloration of the dry socket — No93
Pale discoloration of the dry socket — Unknown0
SecondaryHemostasis

Presence or absence of bleeding in the socket.

Time frame:
Immediately after Alveogyl placement and Day 7 after treatment
Reported as:
Count of participants · Participants
Hemostasis
ParticipantsStudy Population
Presence or absence of bleeding in the socket immediately after Alveogyl placement — Patients without Bleeding96
Presence or absence of bleeding in the socket immediately after Alveogyl placement — Patients showing mild bleeding13
Presence or absence of bleeding in the socket immediately after Alveogyl placement — Patients showing moderate bleeding1
Presence or absence of bleeding in the socket immediately after Alveogyl placement — Patients showing hemorrhagic oozing0
Presence or absence of bleeding in the socket 7 days after Alveogyl placement — Patients without Bleeding110
Presence or absence of bleeding in the socket 7 days after Alveogyl placement — Patients showing mild bleeding0
Presence or absence of bleeding in the socket 7 days after Alveogyl placement — Patients showing moderate bleeding0
Presence or absence of bleeding in the socket 7 days after Alveogyl placement — Patients showing hemorrhagic oozing0
SecondaryComplication Rate

Adverse events occuring within 7 days after treatment

Time frame:
From Alveogyl placement to 7 days post-treatment
Reported as:
Count of participants · Participants
Complication Rate
ParticipantsStudy Population
Patients with adverse events0
Patients without adverse events110

Adverse events

Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Population0/120 (0%)0/120 (0%)0/120 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Study Population
Mean42.6 ± 15.2
Sex: Female, Male
Sex: Female, Male(Participants)Study Population
Female82
Male38
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Study Population
Region of Enrollment
Region of Enrollment(participants)Study Population
France30
India90
08

Study locations

16 sites
  • Hospital Henri-Mondor (AP-HP)
    Créteil, 94000, France
  • Odontology Department - Pitié-Salpêtrière Hospital
    Paris, 75013, France
  • Mallige Hospital
    Bangalore, Karnataka 560001, India
  • Smile Dental Care
    Bangalore, Karnataka 560024, India
  • Perfect Dental Studio
    Bangalore, Karnataka 560076, India
  • Cavalier Hospital
    Bangalore, Karnataka 56009443, India
  • Smile Dental Clinic
    Bangalore, Karnataka 560094, India
  • The Dental Avenues
    Bangalore, Karnataka 560098, India
  • Sri Dental Multispeciality Dental Hospital
    Hyderabad, 500070, India
  • Vrisa Dental
    Hyderabad, 500079, India
  • Eledent International Digital Dentistry
    Hyderabad, 500085, India
  • Vardhaman Dental Care
    Mumbai, 421203, India
  • Mayur Dental Clinic
    Mumbai, 421501, India
  • Smile Gallery Dental Care Center
    Pune, 411004, India
  • Dr. Salke Dental & Implant Centre
    Pune, 411016, India
  • Sri Siddhartha Dental College
    Tumakuru, 572107, India
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2022 to primary completion in Jun 2025, 30 months.

Results were first posted in Feb 2026, 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2022
First posted
Sep 10, 2022
StartActual
Dec 13, 2022
Primary completionActual
Jun 26, 2025
CompletionActual
Jun 26, 2025
Results first posted
Feb 9, 2026
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05536115
Lead sponsor
Septodont
Collaborators
SMO Clinical Research, QualityStat
Responsible party
Sponsor
First posted
Sep 10, 2022
Start date
Dec 13, 2022
Primary completion
Jun 26, 2025
Completion
Jun 26, 2025
Results posted
Feb 9, 2026
Last update
May 14, 2026

Study contacts

Géraldine Lescaille, DDS, PhD
study director · Odontology department - Pitié-Salpêtrière Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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