Impacted Mandibular Third MolarNCT07445724
Cyanoacrylate Adhesive in Impacted Mandibular Third Molars Surgery
A study testing cyanoacrylate tissue adhesive and Silk Sutures in people with Impacted Mandibular Third Molar, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial summary
The goal of this randomized clinical trial is to evaluate whether cyanoacrylate tissue adhesive can improve postoperative outcomes compared with conventional silk sutures in patients undergoing surgical removal of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- cyanoacrylate tissue adhesive and Silk Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesVietnam
- Study dates
- 2 Oct 2025to 7 Aug 2026
- 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
- Patients aged 18 years or older.
- Patients presenting with bilateral mandibular third molars indicated for extraction, with the same level of surgical difficulty according to the Pell-Gregory classification, and an angulation difference between the two teeth not exceeding 15° according to the Winter classification on panoramic radiographs.
- No use of local or systemic antibiotics within 2 weeks prior to surgery.
- Absence of serious systemic diseases such as coagulation disorders or uncontrolled diabetes, and no acute infection at the extraction site.
- Patients who agree to participate in the study after receiving clear explanation and counseling.
Who cannot join
- Patients who are uncooperative in providing necessary information or who decline to continue participation in the study.
- A difference in surgical duration between the two sides exceeding 12 minutes, or the occurrence of intraoperative complications.
- Patients with known hypersensitivity or allergy to any materials used in the study, such as lidocaine local anesthetic, cyanoacrylate adhesive, or suture materials.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
An Binh Hospital
Ho Chi Minh City, Ho Chi Minh City
University of Medicine and Pharmacy at Ho Chi Minh City.
Ho Chi Minh City, Ho Chi Minh City
About this study
Official title: Evaluation of Soft Tissue Healing and Microbiological Status in Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars Using Cyanoacrylate Adhesive
The goal of this randomized clinical trial is to evaluate whether cyanoacrylate tissue adhesive can improve postoperative outcomes compared with conventional silk sutures in patients undergoing surgical removal of impacted mandibular third molars.
The main questions it aims to answer is: Is there a difference in wound healing support, soft-tissue conditions, and microbiological outcomes at the surgical site of impacted mandibular third molar extraction between closure with conventional sutures and cyanoacrylate tissue adhesive? Researchers will compare cyanoacrylate tissue adhesive with conventional silk sutures to determine whether the adhesive provides superior postoperative recovery and periodontal outcomes.
Read more
Participants will:
- Undergo surgical extraction of an impacted mandibular third molar.
- Receive wound closure using either cyanoacrylate tissue adhesive or conventional silk sutures.
- Be followed postoperatively for assessment of pain, swelling, trismus, soft-tissue healing, and periodontal measurements at specified time points.
Read the detailed description
Surgical removal of impacted mandibular third molars is one of the most common procedures in dental practice. Following surgery, conventional wound closure using sutures is widely employed to support healing. However, this method has several limitations, including difficult surgical access to the posterior oral cavity, tissue trauma during suturing, plaque accumulation around the suture site, and the need for suture removal after surgery. These drawbacks create a need for alternative wound-closure approaches. Recently, the development of biomaterials, particularly cyanoacrylate tissue adhesives has introduced a new strategy that may improve healing and reduce postoperative complications.
Cyanoacrylate tissue adhesives have been reported to possess favorable biological properties, including antibacterial activity, hemostatic capability, biodegradability, and biocompatibility with living tissues. Various cyanoacrylate derivatives have been investigated, ranging from methyl, ethyl, and propyl to butyl and octyl cyanoacrylate, among which butyl and octyl forms demonstrate the most favorable clinical performance.
In oral surgery, cyanoacrylate has been recognized as a useful alternative due to its ability to shorten operative time, reduce postoperative pain, and eliminate the need for suture removal after healing. Lascaz Netto and Macedo (1986) evaluated wound healing in patients using cyanoacrylate for gingival graft fixation and reported significantly reduced surgical time with normal postoperative recovery. Cyanoacrylate adhesives have also been applied for multiple clinical purposes, including periodontal dressing, closure of sinus membrane perforations, fixation of bone fragments in fracture surgery, and peripheral nerve repair. In addition, cyanoacrylate has been proposed for wound closure via primary healing and, more recently, for protection of wounds healing by secondary intention.
Although cyanoacrylate tissue adhesives have been widely studied and applied in medicine, limited evidence exists regarding their effectiveness in supporting soft-tissue healing and their impact on the local oral microbiological environment. Moreover, few studies have directly compared tissue adhesives with conventional suturing across multiple bacterial species using modern analytical techniques. Therefore, this study was conducted to evaluate the soft-tissue healing support provided by cyanoacrylate tissue adhesive compared with traditional sutures through three aspects: common postoperative complications (pain, swelling, and trismus), the rate of soft-tissue healing, and changes in the microbiological profile at the surgical site.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- cyanoacrylate tissue adhesive, Silk Sutures
- Keywords
- impacted mandibular third molar, Cyanoacrylate tissue adhesive, Silk suture, Wound closure, Postoperative pain, Soft-tissue healing, Periodontal healing, Oral microbiota, Randomized controlled trial, Oral surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylate tissue adhesiveProcedure or surgery
Following surgical removal of the impacted mandibular third molar, wound closure is achieved by applying cyanoacrylate tissue adhesive along the mucosal margins to approximate the soft tissues without suturing. The adhesive is allowed to polymerize according to the manufacturer's instructions. No sutures are placed at the surgical site. Postoperative care is standardized across study conditions.
Silk SuturesProcedure or surgery
After surgical removal of the impacted mandibular third molar, wound closure is performed using interrupted non-resorbable silk sutures to approximate the mucosal margins. Sutures are removed at the routine postoperative follow-up visit. Postoperative care is identical to that provided in the cyanoacrylate condition.
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate Tissue Adhesive | Experimental | Participants undergoing surgical removal of impacted mandibular third molars receive wound closure using cyanoacrylate tissue adhesive applied to the surgical site according to the manufacturer's instructions. Postoperative care and follow-up procedures are standardized across both study conditions. Receives: Procedure: cyanoacrylate tissue adhesive |
| Conventional Silk Sutures | Active comparator | Participants undergoing surgical removal of impacted mandibular third molars receive conventional wound closure using interrupted silk sutures. Postoperative care and follow-up procedures are identical to those in the cyanoacrylate condition. Receives: Procedure: Silk Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Patients self-assessed their pain intensity using the modified Visual Analog Scale (VAS) according to Kiran Khande (2011) on postoperative days 3 and 7. Accordingly, pain was graded as follows: grade 0 (no pain), the patient feels normal; grade 1 (mild pain), the patient does not notice the pain unless attention is drawn to it; grade 2 (moderate pain), the patient experiences pain even while concentrating on certain activities; grade 3 (severe pain), the patient feels very uncomfortable but is still able to continue normal daily activities; grade 4 (very severe pain), the patient must discontinue normal activities; and grade 5 (extremely severe pain), the patient must stop all activities and lie down to rest. A higher pain grade indicates a more severe postoperative condition following the surgical intervention.
Measured: postoperative days 3 and 7
Secondary outcomes (4)
Swelling
Extraoral swelling was assessed by measuring three facial distances (A, B, C) with a measuring tape applied using light pressure to avoid skin indentation, rounded to the nearest millimeter, with the patient in maximum intercuspation. Segment A was measured from the lateral canthus to the angle of the mandible; segment B from the tragus to the corner of the mouth; and segment C from the tragus to the most anterior-inferior point of the chin.
Objective swelling was evaluated on postoperative days 3 and 7 by repeating the same measurements and calculating changes from baseline. Subjective swelling was assessed on days 3 and 7 using a modified Visual Analog Scale (VAS; Kiran Khande, 2011), graded from 0 (no swelling) to 5 (extremely severe swelling with limited mouth opening). Higher grades indicated more severe postoperative swelling.
Measured: postoperative days 3 and 7
Maximum mouth opening
The patient's maximum mouth opening was measured using a caliper to determine the distance from the incisal edge of the maxillary central incisor to the incisal edge of the corresponding mandibular central incisor on the same side, rounded to the nearest millimeter.
Measured: Postoperative days 3 and 7
Microbiological profile
The investigator collected dental plaque samples from the distal surface of the mandibular second molar using a Gracey curette on postoperative day 7 to evaluate the quantity of the following bacteria: Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Treponema denticola, Streptococcus salivarius, Porphyromonas gingivalis, Prevotella moorei, Tannerella forsythia, Peptostreptococcus stomatis, Eikenella corrodens, Prevotella intermedia, Leptotrichia wadei using the polymerase chain reaction (PCR) technique.
Measured: 7 days after surgery
Soft-tissue healing
Healing was evaluated according to the modified scoring scale of Hamzani (2018) on postoperative days 3, 7, and 30. During the inflammatory phase, a score ranging from 5 to 8 indicated good healing; in the proliferative phase, scores ranged from 3 to 5; and in the remodeling phase, scores ranged from 2 to 3. A higher score corresponded to better soft tissue healing.
Measured: Postoperative days 3, 7, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Oct 2025
- Primary completion15 Jul 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized split-mouth design in which each participant undergoes bilateral mandibular third molar surgery. One surgical site is closed with cyanoacrylate tissue adhesive and the contralateral site with conventional silk sutures, with side allocation determined by randomization. Surgeries may be performed at separate visits according to clinical indications.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bui Nguyen Phuong Thao, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445724
- Sponsor's protocol ID
- IRB-VN01002/IRB00010293
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Healing and Microbiological Status in Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars Using Cyanoacrylate Adhesive
- ClinicalTrials.gov ID
- NCT07445724
- Acronym / sponsor ID
- IRB-VN01002/IRB00010293
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- impacted mandibular third molar, Cyanoacrylate tissue adhesive, Silk suture, Wound closure, Postoperative pain, Soft-tissue healing, Periodontal healing, Oral microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 3 Mar 2026 (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 goal of this randomized clinical trial is to evaluate whether cyanoacrylate tissue adhesive can improve postoperative outcomes compared with conventional silk sutures in patients undergoing surgical removal of impacted mandibular third molars.
The main questions it aims to answer is: Is there a difference in wound healing support, soft-tissue conditions, and microbiological outcomes at the surgical site of impacted mandibular third molar extraction between closure with conventional sutures and cyanoacrylate tissue adhesive? Researchers will compare cyanoacrylate tissue adhesive with conventional silk sutures to determine whether the adhesive provides superior postoperative recovery and periodontal outcomes.
Participants will:
- Undergo surgical extraction of an impacted mandibular third molar.
- Receive wound closure using either cyanoacrylate tissue adhesive or conventional silk sutures.
- Be followed postoperatively for assessment of pain, swelling, trismus, soft-tissue healing, and periodontal measurements at specified time points.
Detailed description
Surgical removal of impacted mandibular third molars is one of the most common procedures in dental practice. Following surgery, conventional wound closure using sutures is widely employed to support healing. However, this method has several limitations, including difficult surgical access to the posterior oral cavity, tissue trauma during suturing, plaque accumulation around the suture site, and the need for suture removal after surgery. These drawbacks create a need for alternative wound-closure approaches. Recently, the development of biomaterials, particularly cyanoacrylate tissue adhesives has introduced a new strategy that may improve healing and reduce postoperative complications.
Cyanoacrylate tissue adhesives have been reported to possess favorable biological properties, including antibacterial activity, hemostatic capability, biodegradability, and biocompatibility with living tissues. Various cyanoacrylate derivatives have been investigated, ranging from methyl, ethyl, and propyl to butyl and octyl cyanoacrylate, among which butyl and octyl forms demonstrate the most favorable clinical performance.
In oral surgery, cyanoacrylate has been recognized as a useful alternative due to its ability to shorten operative time, reduce postoperative pain, and eliminate the need for suture removal after healing. Lascaz Netto and Macedo (1986) evaluated wound healing in patients using cyanoacrylate for gingival graft fixation and reported significantly reduced surgical time with normal postoperative recovery. Cyanoacrylate adhesives have also been applied for multiple clinical purposes, including periodontal dressing, closure of sinus membrane perforations, fixation of bone fragments in fracture surgery, and peripheral nerve repair. In addition, cyanoacrylate has been proposed for wound closure via primary healing and, more recently, for protection of wounds healing by secondary intention.
Although cyanoacrylate tissue adhesives have been widely studied and applied in medicine, limited evidence exists regarding their effectiveness in supporting soft-tissue healing and their impact on the local oral microbiological environment. Moreover, few studies have directly compared tissue adhesives with conventional suturing across multiple bacterial species using modern analytical techniques. Therefore, this study was conducted to evaluate the soft-tissue healing support provided by cyanoacrylate tissue adhesive compared with traditional sutures through three aspects: common postoperative complications (pain, swelling, and trismus), the rate of soft-tissue healing, and changes in the microbiological profile at the surgical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized split-mouth design in which each participant undergoes bilateral mandibular third molar surgery. One surgical site is closed with cyanoacrylate tissue adhesive and the contralateral site with conventional silk sutures, with side allocation determined by randomization. Surgeries may be performed at separate visits according to clinical indications.
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate Tissue Adhesive | Experimental | Procedure: cyanoacrylate tissue adhesiveParticipants undergoing surgical removal of impacted mandibular third molars receive wound closure using cyanoacrylate tissue adhesive applied to the surgical site according to the manufacturer's instructions. Postoperative care and follow-up procedures are standardized across both study conditions. |
| Conventional Silk Sutures | Active comparator | Procedure: Silk SuturesParticipants undergoing surgical removal of impacted mandibular third molars receive conventional wound closure using interrupted silk sutures. Postoperative care and follow-up procedures are identical to those in the cyanoacrylate condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Patients presenting with bilateral mandibular third molars indicated for extraction, with the same level of surgical difficulty according to the Pell-Gregory classification, and an angulation difference between the two teeth not exceeding 15° according to the Winter classification on panoramic radiographs.
- No use of local or systemic antibiotics within 2 weeks prior to surgery.
- Absence of serious systemic diseases such as coagulation disorders or uncontrolled diabetes, and no acute infection at the extraction site.
- Patients who agree to participate in the study after receiving clear explanation and counseling.
Key exclusion criteria (3 listed)
- Patients who are uncooperative in providing necessary information or who decline to continue participation in the study.
- A difference in surgical duration between the two sides exceeding 12 minutes, or the occurrence of intraoperative complications.
- Patients with known hypersensitivity or allergy to any materials used in the study, such as lidocaine local anesthetic, cyanoacrylate adhesive, or suture materials.
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 |
|---|---|---|
| cyanoacrylate tissue adhesiveFollowing surgical removal of the impacted mandibular third molar, wound closure is achieved by applying cyanoacrylate tissue adhesive along the mucosal margins to approximate the soft tissues without suturing. The adhesive is allowed to polymerize according to the manufacturer's instructions. No sutures are placed at the surgical site. Postoperative care is standardized across study conditions. | Procedure or surgery | Cyanoacrylate Tissue Adhesive |
| Silk SuturesAfter surgical removal of the impacted mandibular third molar, wound closure is performed using interrupted non-resorbable silk sutures to approximate the mucosal margins. Sutures are removed at the routine postoperative follow-up visit. Postoperative care is identical to that provided in the cyanoacrylate condition. | Procedure or surgery | Conventional Silk Sutures |
Primary outcome
Postoperative pain
Time frame: postoperative days 3 and 7
Patients self-assessed their pain intensity using the modified Visual Analog Scale (VAS) according to Kiran Khande (2011) on postoperative days 3 and 7. Accordingly, pain was graded as follows: grade 0 (no pain), the patient feels normal; grade 1 (mild pain), the patient does not notice the pain unless attention is drawn to it; grade 2 (moderate pain), the patient experiences pain even while concentrating on certain activities; grade 3 (severe pain), the patient feels very uncomfortable but is still able to continue normal daily activities; grade 4 (very severe pain), the patient must discontinue normal activities; and grade 5 (extremely severe pain), the patient must stop all activities and lie down to rest. A higher pain grade indicates a more severe postoperative condition following the surgical intervention.
4 secondary outcomes
Swelling
Time frame: postoperative days 3 and 7
Maximum mouth opening
Time frame: Postoperative days 3 and 7
Microbiological profile
Time frame: 7 days after surgery
Soft-tissue healing
Time frame: Postoperative days 3, 7, and 30
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 2 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyanoacrylate tissue adhesive and Silk Sutures in people with Impacted Mandibular Third Molar, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
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 5 inclusion and 3 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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?
Postoperative pain (time frame: postoperative days 3 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.