Non-restorable TeethKBA vs CANCT07491276
Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions
A study testing PDO Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue (PERIACRYL) and 3/0 Resorbable PGA Suture in people with Non-restorable Teeth and Intraoral Surgical Incisions, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This clinical study aims to compare the efficacy of knotless barbed sutures versus N-butyl cyanoacrylate glue tissue adhesive for the closure of intra-oral surgical incisions, with traditional PGA vicryl sutures as a control group. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-restorable Teeth, Intraoral Surgical Incisions, Wound Closure
- What is being tested?
- PDO Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue (PERIACRYL) and 3/0 Resorbable PGA Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring Intra-oral wound closure following intra-oral incisions after surgical extraction of non-restorable teeth.
- Good oral hygiene.
- Highly motivated patients
- Patients agreed to follow-up for post-operative evaluation with informed consent
- Age between 18- 50 years old
- Both genders: Males \& Females
Who cannot join
- Medically compromised patients as uncontrolled Diabetes, uncontrolled hypertension.
- Patients on chemotherapy or radiation.
- Patients with bad oral hygiene .
- Uncooperative patients: mentally retarded patients.
- Heavy smokers. ( > 1 pack/day).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Future University in Egypt
New Cairo, Cairo Governorate, 11835
About this study
Official title: Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions (Randomized Controlled Clinical Study).
This clinical study aims to compare the efficacy of knotless barbed sutures versus N-butyl cyanoacrylate glue tissue adhesive for the closure of intra-oral surgical incisions, with traditional PGA vicryl sutures as a control group. The study evaluates three primary outcomes: the time required for incision closure, postoperative pain levels using the Visual Analog Scale (VAS) score, and the soft tissue healing progress using Landry's wound healing index. Secondary outcomes will include the assessment of postoperative edema and other clinical healing parameters. The goal is to determine which closure technique provides superior surgical efficiency, less patient discomfort, and better wound healing in oral and maxillofacial procedures.
Read the detailed description
Background and Rationale:
Conventional intraoral suturing requires the placement of knots to secure the material and maintain tension. However, this presents technical challenges such as restricted access and difficulty in instrumentation. Knots are also associated with complications like food debris accumulation, microbial colonization, and tissue irritation. This study evaluates two modern alternatives-knotless barbed sutures and N-butyl cyanoacrylate glue-to overcome these limitations.
Objectives:
The primary objective is to compare the efficacy of knotless barbed sutures and N-butyl cyanoacrylate glue against traditional resorbable PGA sutures for intraoral surgical incisions. The study focuses on improving wound closure, healing, and decreasing post-operative pain and edema.
Methods:
This randomized controlled clinical trial includes 30 patients (18-50 years old) requiring surgical extraction of non-restorable teeth. Participants are randomly assigned to three groups:
- Group A: Closure using PDO Knotless barbed sutures (RTMED).
- Group B: Closure using N-butyl cyanoacrylate glue (PERIACRYL).
- Group C (Control): Closure using 3/0 resorbable PGA sutures.
Procedures and Follow-up:
After surgical extraction under local anesthesia, the wound is closed according to the assigned group. Post-operative care includes antibiotics (Amoxicillin) and analgesics (Diclofenac potassium). Patients are evaluated on the 1st, 3rd, and 7th post-operative days.
Outcome Measures:
- Primary Outcomes: Wound closure time (seconds), post-operative pain (VAS score), and wound healing (Landry's index).
- Secondary Outcomes: Post-operative edema (mm) and assessment of complications like dehiscence or infection.
- Conditions
- Non-restorable Teeth, Intraoral Surgical Incisions, Wound Closure, Surgical Tooth Extraction
- Being tested
- PDO Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue (PERIACRYL), 3/0 Resorbable PGA Suture
- Keywords
- Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue, Tissue Adhesive, Wound Healing, Post-operative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDO Knotless Barbed SutureDevice
A self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure.
N-Butyl Cyanoacrylate Glue (PERIACRYL)Device
A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier.
3/0 Resorbable PGA SutureDevice
Conventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Knotless Barbed Suture | Experimental | 10 patients will receive wound closure using PDO Knotless barbed suture material (RTMED) after surgical extraction. Receives: Device: PDO Knotless Barbed Suture |
| Group B: N-Butyl Cyanoacrylate Glue | Experimental | 10 patients will receive wound closure using N-butyl cyanoacrylate glue (PERIACRYL) after surgical extraction. Receives: Device: N-Butyl Cyanoacrylate Glue (PERIACRYL) |
| Group C: Conventional PGA Suture | Active comparator | 10 patients will receive wound closure using traditional 3/0 resorbable polyglycolic acid (PGA) sutures after surgical extraction. Receives: Device: 3/0 Resorbable PGA Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure Time
The total duration required to achieve clinical closure of the intraoral surgical incision. Measurement starts from the first needle penetration (for suture groups) or the beginning of adhesive application (for the glue group) and ends when the wound edges are fully secured.
Measured: Intra-operatively (at the time of surgery_
Post-operative Pain Level
Assessment of patient discomfort using the Visual Analogue Scale (VAS). The scale consists of a 10-cm horizontal line with "No Pain" at 0 and "Worst Imaginable Pain" at 10. Patients will mark their perceived pain level on this line.
Measured: 1st, 3rd, and 7th post-operative days.
Soft Tissue Healing
Clinical assessment of the surgical site healing using Landry's Wound Healing Index. This index evaluates five clinical parameters: tissue color, response to palpation, presence of granulation tissue, incision margin, and presence of suppuration. Scores range from 1 (Very Poor) to 5 (Excellent).
Measured: 1st, 3rd, and 7th post-operative days.
Secondary outcomes (2)
Post-operative Edema
Clinical assessment of facial swelling after surgery, categorized as (None, Mild, Moderate, or Severe).
Measured: 1st, 3rd, and 7th post-operative days.
Wound Dehiscence
Presence or absence of any separation of the wound margins after suture or glue application.
Measured: 1st, 3rd, and 7th post-operative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start16 Jun 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-restorable TeethStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, three-arm, parallel-group clinical trial. Participants requiring surgical extraction of non-restorable teeth are randomly allocated into one of three groups to compare different wound closure techniques: knotless barbed sutures, N-butyl cyanoacrylate glue, and conventional resorbable PGA sutures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Mohamed Kenany, Future University in Egypt
- Investigators
- Lobna Abdel Aziz, PHD, Study chair, Faculty of oral & dental medicine, Future University in EgyptMahmoud Mohsen El Arini, PHD, Study director, Faculty of oral & dental medicine, Future University in EgyptAbeer Kamal, PHD, Study chair, Faculty of oral & dental medicine, Misr university for science & technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491276
- Sponsor's protocol ID
- KBS vs CA in surgical wounds
- Acronym
- KBA vs CA
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are not available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions (Randomized Controlled Clinical Study).
- ClinicalTrials.gov ID
- NCT07491276
- Acronym / sponsor ID
- KBA vs CA / KBS vs CA in surgical wounds
- Conditions
- Non-restorable Teeth, Intraoral Surgical Incisions, Wound Closure, Surgical Tooth Extraction
- Keywords
- Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue, Tissue Adhesive, Wound Healing, Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 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.
This clinical study aims to compare the efficacy of knotless barbed sutures versus N-butyl cyanoacrylate glue tissue adhesive for the closure of intra-oral surgical incisions, with traditional PGA vicryl sutures as a control group. The study evaluates three primary outcomes: the time required for incision closure, postoperative pain levels using the Visual Analog Scale (VAS) score, and the soft tissue healing progress using Landry's wound healing index. Secondary outcomes will include the assessment of postoperative edema and other clinical healing parameters. The goal is to determine which closure technique provides superior surgical efficiency, less patient discomfort, and better wound healing in oral and maxillofacial procedures.
Detailed description
Background and Rationale:
Conventional intraoral suturing requires the placement of knots to secure the material and maintain tension. However, this presents technical challenges such as restricted access and difficulty in instrumentation. Knots are also associated with complications like food debris accumulation, microbial colonization, and tissue irritation. This study evaluates two modern alternatives-knotless barbed sutures and N-butyl cyanoacrylate glue-to overcome these limitations.
Objectives:
The primary objective is to compare the efficacy of knotless barbed sutures and N-butyl cyanoacrylate glue against traditional resorbable PGA sutures for intraoral surgical incisions. The study focuses on improving wound closure, healing, and decreasing post-operative pain and edema.
Methods:
This randomized controlled clinical trial includes 30 patients (18-50 years old) requiring surgical extraction of non-restorable teeth. Participants are randomly assigned to three groups:
- Group A: Closure using PDO Knotless barbed sutures (RTMED).
- Group B: Closure using N-butyl cyanoacrylate glue (PERIACRYL).
- Group C (Control): Closure using 3/0 resorbable PGA sutures.
Procedures and Follow-up:
After surgical extraction under local anesthesia, the wound is closed according to the assigned group. Post-operative care includes antibiotics (Amoxicillin) and analgesics (Diclofenac potassium). Patients are evaluated on the 1st, 3rd, and 7th post-operative days.
Outcome Measures:
- Primary Outcomes: Wound closure time (seconds), post-operative pain (VAS score), and wound healing (Landry's index).
- Secondary Outcomes: Post-operative edema (mm) and assessment of complications like dehiscence or infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a randomized, three-arm, parallel-group clinical trial. Participants requiring surgical extraction of non-restorable teeth are randomly allocated into one of three groups to compare different wound closure techniques: knotless barbed sutures, N-butyl cyanoacrylate glue, and conventional resorbable PGA sutures.
| Arm | Type | Receives |
|---|---|---|
| Group A: Knotless Barbed Suture | Experimental | Device: PDO Knotless Barbed Suture10 patients will receive wound closure using PDO Knotless barbed suture material (RTMED) after surgical extraction. |
| Group B: N-Butyl Cyanoacrylate Glue | Experimental | Device: N-Butyl Cyanoacrylate Glue (PERIACRYL)10 patients will receive wound closure using N-butyl cyanoacrylate glue (PERIACRYL) after surgical extraction. |
| Group C: Conventional PGA Suture | Active comparator | Device: 3/0 Resorbable PGA Suture10 patients will receive wound closure using traditional 3/0 resorbable polyglycolic acid (PGA) sutures after surgical extraction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients requiring Intra-oral wound closure following intra-oral incisions after surgical extraction of non-restorable teeth.
- Good oral hygiene.
- Highly motivated patients
- Patients agreed to follow-up for post-operative evaluation with informed consent
- Age between 18- 50 years old
Key exclusion criteria (5 listed)
- Medically compromised patients as uncontrolled Diabetes, uncontrolled hypertension.
- Patients on chemotherapy or radiation.
- Patients with bad oral hygiene .
- Uncooperative patients: mentally retarded patients.
- Heavy smokers. ( > 1 pack/day).
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 |
|---|---|---|
| PDO Knotless Barbed SutureA self-securing monofilament suture with microscopic barbs that eliminate the need for surgical knots during wound closure. | Device | Group A: Knotless Barbed Suture |
| N-Butyl Cyanoacrylate Glue (PERIACRYL)A bacteriostatic tissue adhesive applied to approximated wound edges to provide secure closure and a microbial barrier. | Device | Group B: N-Butyl Cyanoacrylate Glue |
| 3/0 Resorbable PGA SutureConventional polyglycolic acid (PGA) resorbable sutures used with standard surgical knot-tying techniques. | Device | Group C: Conventional PGA Suture |
Primary outcome
Wound Closure Time
Time frame: Intra-operatively (at the time of surgery_
The total duration required to achieve clinical closure of the intraoral surgical incision. Measurement starts from the first needle penetration (for suture groups) or the beginning of adhesive application (for the glue group) and ends when the wound edges are fully secured.
Post-operative Pain Level
Time frame: 1st, 3rd, and 7th post-operative days.
Assessment of patient discomfort using the Visual Analogue Scale (VAS). The scale consists of a 10-cm horizontal line with "No Pain" at 0 and "Worst Imaginable Pain" at 10. Patients will mark their perceived pain level on this line.
Soft Tissue Healing
Time frame: 1st, 3rd, and 7th post-operative days.
Clinical assessment of the surgical site healing using Landry's Wound Healing Index. This index evaluates five clinical parameters: tissue color, response to palpation, presence of granulation tissue, incision margin, and presence of suppuration. Scores range from 1 (Very Poor) to 5 (Excellent).
2 secondary outcomes
Post-operative Edema
Time frame: 1st, 3rd, and 7th post-operative days.
Wound Dehiscence
Time frame: 1st, 3rd, and 7th post-operative days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. Data are not available due to privacy and ethical restrictions.
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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.
Lobna Abdel Aziz, PHD study chair
Faculty of oral & dental medicine, Future University in Egypt
Mahmoud Mohsen El Arini, PHD study director
Faculty of oral & dental medicine, Future University in Egypt
Abeer Kamal, PHD study chair
Faculty of oral & dental medicine, Misr university for science & technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDO Knotless Barbed Suture, N-Butyl Cyanoacrylate Glue (PERIACRYL) and 3/0 Resorbable PGA Suture in people with Non-restorable Teeth and Intraoral Surgical Incisions, run by Future University in Egypt at 1 site in Egypt.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Wound Closure Time (time frame: Intra-operatively (at the time of surgery_). 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?
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 25 Mar 2026.