Trial Outcomes & Findings for Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket (NCT NCT05536115)
NCT ID: NCT05536115
Last Updated: 2026-05-14
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
120 participants
Primary outcome timeframe
7 days post-treatment
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Study Population
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Overall Study
STARTED
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120
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Overall Study
COMPLETED
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115
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Population
n=120 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Age, Continuous
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42.6 years
STANDARD_DEVIATION 15.2 • n=120 Participants
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Sex: Female, Male
Female
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82 Participants
n=120 Participants
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Sex: Female, Male
Male
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38 Participants
n=120 Participants
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Region of Enrollment
France
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30 participants
n=120 Participants
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Region of Enrollment
India
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90 participants
n=120 Participants
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PRIMARY outcome
Timeframe: 7 days post-treatmentPopulation: PP Population
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.
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Pain Using a Visual Analog Scale (VAS : 0-10)
Success : Patients with no pain or mild pain at Day7 (VAS<4)
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106 Participants
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Pain Using a Visual Analog Scale (VAS : 0-10)
Failure : Patients with moderate to severe pain at Day 7 (VAS ≥ 4)
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4 Participants
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SECONDARY outcome
Timeframe: 3 and 5 days post-treatmentPopulation: PP population
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
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Analgesic Use
Patient reporting a painkiller intake at 3 days after treatment with Alveogyl · Patient reporting a painkiller intake
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63 Participants
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Analgesic Use
Patient reporting a painkiller intake at 3 days after treatment with Alveogyl · Patient not reporting a painkiller intake
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47 Participants
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Analgesic Use
Patients reporting a painkiller intake at 5 days after treatment with Alveogyl · Patient reporting a painkiller intake
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20 Participants
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Analgesic Use
Patients reporting a painkiller intake at 5 days after treatment with Alveogyl · Patient not reporting a painkiller intake
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90 Participants
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SECONDARY outcome
Timeframe: 7 days post-treatmentHealing 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.
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Healing of the Alveolar Mucosa
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4.0 Wound healing index Score
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: 7 days post-treatmentSigns of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment with Alveogyl
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Signs of Local Inflammation
patients showing signs of inflammation around the gingival mucosa
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19 Participants
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Signs of Local Inflammation
patients without signs of inflammation around the gingival mucosa
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91 Participants
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SECONDARY outcome
Timeframe: 7 days post-treatmentPopulation: PP population
Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Antiseptic Effect
Halitosis / bad breath · Yes
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12 Participants
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Antiseptic Effect
Halitosis / bad breath · No
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96 Participants
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Antiseptic Effect
Halitosis / bad breath · Unknown
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2 Participants
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Antiseptic Effect
Fever · Yes
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2 Participants
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Antiseptic Effect
Fever · No
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108 Participants
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Antiseptic Effect
Fever · Unknown
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0 Participants
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Antiseptic Effect
Tenderness of the gingival mucosa · Yes
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24 Participants
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Antiseptic Effect
Tenderness of the gingival mucosa · No
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86 Participants
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Antiseptic Effect
Tenderness of the gingival mucosa · Unknown
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0 Participants
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Antiseptic Effect
Purulent collection in the alveolus and gingival mucosa · Yes
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0 Participants
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Antiseptic Effect
Purulent collection in the alveolus and gingival mucosa · No
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110 Participants
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Antiseptic Effect
Purulent collection in the alveolus and gingival mucosa · Unknown
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0 Participants
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Antiseptic Effect
Pale discoloration of the dry socket · Yes
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17 Participants
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Antiseptic Effect
Pale discoloration of the dry socket · No
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93 Participants
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Antiseptic Effect
Pale discoloration of the dry socket · Unknown
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0 Participants
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SECONDARY outcome
Timeframe: Immediately after Alveogyl placement and Day 7 after treatmentPopulation: PP population
Presence or absence of bleeding in the socket.
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Hemostasis
Presence or absence of bleeding in the socket immediately after Alveogyl placement · Patients without Bleeding
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96 Participants
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Hemostasis
Presence or absence of bleeding in the socket immediately after Alveogyl placement · Patients showing mild bleeding
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13 Participants
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Hemostasis
Presence or absence of bleeding in the socket immediately after Alveogyl placement · Patients showing moderate bleeding
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1 Participants
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Hemostasis
Presence or absence of bleeding in the socket immediately after Alveogyl placement · Patients showing hemorrhagic oozing
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0 Participants
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Hemostasis
Presence or absence of bleeding in the socket 7 days after Alveogyl placement · Patients without Bleeding
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110 Participants
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Hemostasis
Presence or absence of bleeding in the socket 7 days after Alveogyl placement · Patients showing mild bleeding
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0 Participants
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Hemostasis
Presence or absence of bleeding in the socket 7 days after Alveogyl placement · Patients showing moderate bleeding
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0 Participants
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Hemostasis
Presence or absence of bleeding in the socket 7 days after Alveogyl placement · Patients showing hemorrhagic oozing
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0 Participants
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SECONDARY outcome
Timeframe: From Alveogyl placement to 7 days post-treatmentAdverse events occuring within 7 days after treatment
Outcome measures
| Measure |
Study Population
n=110 Participants
Study patients are patients with post-extraction dry socket.
Alveogyl: 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.
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Complication Rate
Patients with adverse events
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0 Participants
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Complication Rate
Patients without adverse events
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110 Participants
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Adverse Events
Study Population
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place