Impacted Third Molar ToothPhase 4NCT06144983
Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar
A Phase 4 study testing Alvogyl and Chlorhexidine Gluconate in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
Trial summary
Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Alvogyl and Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2022to 1 Sep 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of any history of systemic diseases that can impede wound healing or surgical operation.
- No history of recently using anti-inflammatory drugs.
- Patients aged ≥18 years who were indicated for surgical extraction of mesioangular, class I or II, and position A or B impacted mandibular third molar.
- Well-educated patients who had no objection to take part in the study and likely to comply with all study procedures.
Who cannot join
- Medical conditions that forbid surgical involvement, such as those in patients with bleeding-related conditions, recent myocardial infarctions, psychological issues, uncontrolled systemic diseases, immune-compromised patients, and patients who were on corticosteroid anti-inflammatory drugs.
- Recent history of head and neck radiotherapy.
- Pregnancy, and female patients taking contraceptives.
- Patients with severe localized infections in relation to the third molar, such as Pericoronitis, or those with severe periodontal disease and/or poor oral hygiene.
- Patients who were unable to come back for follow-up and recall appointments.
- Impacted third molar that interferes with the inferior alveolar nerve.
- Periapical pathology or cystic lesions related to the impacted tooth.
- Heavy smokers (more than 20 cigarettes/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar (Comparative Study)
Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes.
To the best of our knowledge, few clinical researchers have investigated the effect of local application of Alvogyl paste and Chlorhexidine gel, in the management of pain, facial swelling, and trismus resulting from lower third molar surgical extraction.
Aim of the study: The study was meant to compare the effects of 0.2% chlorhexidine gel and Alvogyl paste on the reduction of the inflammatory reaction caused by the surgical extraction of the impacted mandibular third molar, which includes pain, facial swelling, and trismus.
Read the detailed description
Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes.
Aim of the study: The study was meant to compare the effects of 0.2% chlorhexidine gel and Alvogyl paste on the reduction of the inflammatory reaction caused by the surgical extraction of the impacted mandibular third molar, which includes pain, facial swelling, and trismus.
Materials and Methods: This randomized control study was conducted from February 2022 to September 2022 on (51) patients, (23) male and (28) female, aged (18-39) years, who presented with impacted mandibular third molar. The participants were randomly allocated into three groups, 17 patients received Alvogyl paste (G1), 17 patients received 0.2% Chlorhexidine gel (Periokin) (G2), and 17 patients received nothing upon surgery (G3). The mouth opening and facial measurements were assessed preoperatively as a baseline reference and on the 2nd and 7th postoperative days. pain was assessed daily using a numerical rating scale (NRS) from the first day to the seventh day following surgery.
Results: Regarding the mouth opening, there was no statistically significant difference among the three groups in the degree of trismus on the second and seventh postoperative days (P ≥ 0.05).
In regards to postoperative facial edema and pain, there was a statistically significant difference among all groups (P < 0.05), however, there was no statistically significant difference between the two study groups.
Conclusion: This study showed that Alvogyl paste and 0.2% Chlorhexidine bioadhesive gel significantly reduce postoperative pain and facial swelling with no significant effect on trismus following impacted mandibular third molar surgical extraction.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Alvogyl, Chlorhexidine Gluconate
- Keywords
- chlorhexidine gel, Impacted Third Molar Tooth, alvogyl paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvogylDrug
Also called Alvogyl paste
In the first study group, (0.2gm) of Alvogyl paste (Septodont Inc., France), was inserted inside the alveolus, filling it entirely
Chlorhexidine GluconateDrug
Also called 0.2% Chlorhexidine gel
in the second group (1ml) of Periokin (Kin Inc., Spain), containing 0.2% Chlorhexidine bioadhesive gel was injected to fill the entire socket
| Study group | Role | What they receive |
|---|---|---|
| Alvogyl paste | Experimental | Application of 0.2 gm of Alvogyl paste inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery. Receives: Drug: Alvogyl |
| Cholrhexidine gel | Experimental | Application of 1 ml of Chlorhexidine gel inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery. Receives: Drug: Chlorhexidine Gluconate |
| control | No intervention | no dressing material was applied following the impacted mandibular third molar surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative trismus
A traditional Vernia caliper is used to measure the distance between the incisal edges of the upper and lower central incisors
Measured: preoperativly and in the second and seventh postoperative day
postoperative swelling
Facial edema was assessed by measuring the distances between three selected lines, utilizing measuring tape, including the tragus of the ear to the outer corner of the mouth, the tragus to the soft tissue pogonion, and the distance that exists between the outer canthus of the eye and the angle of the mandible.
Measured: preoperativly and in the second and seventh postoperative day
postoperative pain
The intensity of pain was assessed using the numeric rating scale (NRS), on which extreme scores start from zero (no pain) to 10 (worst pain possible). The recording of the pain was on two occasions, one at 10 o'clock am and the other at 10 o'clock pm at the same time except for the operation day in which the first recording was 4 hours after surgery and the second was at 10 o'clock pm, the mean of two records represented the pain for that day.
The pain was recorded from the day of the operation until the seventh day. The scale was explained to every patient clearly as (0) represents the absence of pain, (1-2) simple pain, (3-4) low pain, (5-6) moderate tolerable pain, (7-8) intolerable severe pain that can be relieved by medication, and (9-10) intolerable severe pain not relieved by medication.
Measured: throughout the first postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Feb 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Haleem Alaa Abdul Zahra, University of Baghdad
- Investigators
- Sahar sh Aladili, B.D.S.MS.C, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144983
- Sponsor's protocol ID
- 417121
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jesudasan JS, Wahab PU, Sekhar MR. Effectiveness of 0.2% chlorhexidine gel and a eugenol-based paste on postoperative alveolar osteitis in patients having third molars extracted: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2015 Nov;53(9):826-30. doi: 10.1016/j.bjoms.2015.06.022. Epub 2015 Jul 16.
PubMed 26188932
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Gel Versus Alvogyl Following Surgical Extraction of Impacted Mandibular Third Molar (Comparative Study)
- ClinicalTrials.gov ID
- NCT06144983
- Acronym / sponsor ID
- 417121
- Conditions
- Impacted Third Molar Tooth
- Keywords
- chlorhexidine gel, Impacted Third Molar Tooth, alvogyl paste
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Nov 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.
Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes.
To the best of our knowledge, few clinical researchers have investigated the effect of local application of Alvogyl paste and Chlorhexidine gel, in the management of pain, facial swelling, and trismus resulting from lower third molar surgical extraction.
Aim of the study: The study was meant to compare the effects of 0.2% chlorhexidine gel and Alvogyl paste on the reduction of the inflammatory reaction caused by the surgical extraction of the impacted mandibular third molar, which includes pain, facial swelling, and trismus.
Detailed description
Background: One of the most frequent surgical operations in dentistry is the surgical extraction of the impacted mandibular third molar, which is accompanied by a sequelae of swelling, trismus, and pain. Various techniques have been employed to either prevent or reduce these postoperative outcomes.
Aim of the study: The study was meant to compare the effects of 0.2% chlorhexidine gel and Alvogyl paste on the reduction of the inflammatory reaction caused by the surgical extraction of the impacted mandibular third molar, which includes pain, facial swelling, and trismus.
Materials and Methods: This randomized control study was conducted from February 2022 to September 2022 on (51) patients, (23) male and (28) female, aged (18-39) years, who presented with impacted mandibular third molar. The participants were randomly allocated into three groups, 17 patients received Alvogyl paste (G1), 17 patients received 0.2% Chlorhexidine gel (Periokin) (G2), and 17 patients received nothing upon surgery (G3). The mouth opening and facial measurements were assessed preoperatively as a baseline reference and on the 2nd and 7th postoperative days. pain was assessed daily using a numerical rating scale (NRS) from the first day to the seventh day following surgery.
Results: Regarding the mouth opening, there was no statistically significant difference among the three groups in the degree of trismus on the second and seventh postoperative days (P ≥ 0.05).
In regards to postoperative facial edema and pain, there was a statistically significant difference among all groups (P < 0.05), however, there was no statistically significant difference between the two study groups.
Conclusion: This study showed that Alvogyl paste and 0.2% Chlorhexidine bioadhesive gel significantly reduce postoperative pain and facial swelling with no significant effect on trismus following impacted mandibular third molar surgical extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alvogyl paste | Experimental | Drug: AlvogylApplication of 0.2 gm of Alvogyl paste inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery. |
| Cholrhexidine gel | Experimental | Drug: Chlorhexidine GluconateApplication of 1 ml of Chlorhexidine gel inside the extraction socket filling it entirely, and suturing the flap interrupted suture following impacted mandibular third molar surgery. |
| control | No intervention | –no dressing material was applied following the impacted mandibular third molar surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absence of any history of systemic diseases that can impede wound healing or surgical operation.
- No history of recently using anti-inflammatory drugs.
- Patients aged ≥18 years who were indicated for surgical extraction of mesioangular, class I or II, and position A or B impacted mandibular third molar.
- Well-educated patients who had no objection to take part in the study and likely to comply with all study procedures.
Key exclusion criteria (8 listed)
- Medical conditions that forbid surgical involvement, such as those in patients with bleeding-related conditions, recent myocardial infarctions, psychological issues, uncontrolled systemic diseases, immune-compromised patients, and patients who were on corticosteroid anti-inflammatory drugs.
- Recent history of head and neck radiotherapy.
- Pregnancy, and female patients taking contraceptives.
- Patients with severe localized infections in relation to the third molar, such as Pericoronitis, or those with severe periodontal disease and/or poor oral hygiene.
- Patients who were unable to come back for follow-up and recall appointments.
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 |
|---|---|---|
| AlvogylAlso: Alvogyl pasteIn the first study group, (0.2gm) of Alvogyl paste (Septodont Inc., France), was inserted inside the alveolus, filling it entirely | Drug | Alvogyl paste |
| Chlorhexidine GluconateAlso: 0.2% Chlorhexidine gelin the second group (1ml) of Periokin (Kin Inc., Spain), containing 0.2% Chlorhexidine bioadhesive gel was injected to fill the entire socket | Drug | Cholrhexidine gel |
Primary outcome
postoperative trismus
Time frame: preoperativly and in the second and seventh postoperative day
A traditional Vernia caliper is used to measure the distance between the incisal edges of the upper and lower central incisors
postoperative swelling
Time frame: preoperativly and in the second and seventh postoperative day
Facial edema was assessed by measuring the distances between three selected lines, utilizing measuring tape, including the tragus of the ear to the outer corner of the mouth, the tragus to the soft tissue pogonion, and the distance that exists between the outer canthus of the eye and the angle of the mandible.
postoperative pain
Time frame: throughout the first postoperative week
The intensity of pain was assessed using the numeric rating scale (NRS), on which extreme scores start from zero (no pain) to 10 (worst pain possible). The recording of the pain was on two occasions, one at 10 o'clock am and the other at 10 o'clock pm at the same time except for the operation day in which the first recording was 4 hours after surgery and the second was at 10 o'clock pm, the mean of two records represented the pain for that day. The pain was recorded from the day of the operation until the seventh day. The scale was explained to every patient clearly as (0) represents the absence of pain, (1-2) simple pain, (3-4) low pain, (5-6) moderate tolerable pain, (7-8) intolerable severe pain that can be relieved by medication, and (9-10) intolerable severe pain not relieved by medication.
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 22 Nov 2023.
- Background: PubMed 26188932Jesudasan JS, Wahab PU, Sekhar MR. Effectiveness of 0.2% chlorhexidine gel and a eugenol-based paste on postoperative alveolar osteitis in patients having third molars extracted: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2015 Nov;53(9):826-30. doi: 10.1016/j.bjoms.2015.06.022. Epub 2015 Jul 16.
- Individual participant dataSharing planned: No
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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.
Sahar sh Aladili, B.D.S.MS.C study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alvogyl and Chlorhexidine Gluconate in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
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 8 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 22 Nov 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 Iraq. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative trismus (time frame: preoperativly and in the second and seventh postoperative day). The study lists 3 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 NCT06144983, which also lists 1 linked publication.
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 22 Nov 2023.