High Frenum AttachmentNCT06331325
Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults
A study testing Frenotomy and Frenectomy in people with High Frenum Attachment, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are: Does Frenotomy procedure have a lower relapse rate compared to frenectomy? Does Frenotomy procedure result in fewer… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Frenum Attachment
- What is being tested?
- Frenotomy and Frenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 15 Dec 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults with active highly attached maxillary/mandibular labial frenum.
- Systemically healthy
- Non-smokers
- Gingival and plaque index <10%
Who cannot join
- Poor oral hygiene.
- Smokers
- Any systemic diseases or medications that delay wound healing.
- Pregnant or lactating females
- Previous frenal procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Frenotomy and Frenectomy Surgical Techniques for Management of High Frenum Attachment in Adult Patients: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:
- Does Frenotomy procedure have a lower relapse rate compared to frenectomy?
- Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week.
Read the detailed description
Frenum is a triangular thin folded mucus membrane with underlying connective tissue and muscular fibers that attaches the lips and cheeks with alveolar mucosa enhancing the stability of the lip (Newman et al., 2020).
High frenum attachment can have numerous negative effects when highly attached close to the gingival margin including gingival recession, papilla loss, and obliteration of the sulcus, which might enhance plaque accumulation indirectly by hindering tooth brushing. It may also be responsible for midline diastema (Miller, 1985).
According to Mirko et al. (1974), there are four different types of labial frenal attachments: mucosal, gingival, papillary, and papilla piercing. The mucosal form is the most common and predominates in the mandible (Jańczuk \& Banach, 1980).
Frenectomy procedure involves the complete removal of the frenum along with its attachment to the underlying bone. Frenotomy procedure is the incision and relocation of the frenal attachments to a more apical level (Dibart \& Karima, 2008). However, this procedure is not well-documented in the literature and little is known about its expected relapse rates.
The rationale for conducting the research:
The traditional frenectomy procedure as described by Archer (1961) and Kruger (1964) could be considered invasive and may lead to scarring, delayed healing, and loss of the interdental papilla due to bone exposure and complete removal of fibers which may have negative esthetic outcome in addition to the frequent relapse rate (Devishree et al., 2012). A systematic review (Delli et al., 2013) discussed some complications that may arise when performing frenectomy procedure such as scar formation, postoperative pain, and swelling. Thus, frenectomy is considered a radical procedure with potential complications.
In contrast, frenotomy could be introduced as a more conservative procedure that can achieve the same outcomes with lower postoperative complications and scar formation. To the best of our knowledge, no studies are comparing both techniques in terms of relapse rate and postoperative pain.
Thus, the rationale of our study is to evaluate the clinical effectiveness of frenotomy procedure and its effect on frenum relapse and postoperative pain compared to the conventional frenectomy procedure.
- Conditions
- High Frenum Attachment
- Being tested
- Frenotomy, Frenectomy
- Keywords
- frenum, labial, frenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrenotomyProcedure or surgery
Also called Frenal relocation
Partial thickness procedure aiming to relocate high frenum attachment to a more apical level.
FrenectomyProcedure or surgery
Full-thickness excision of the frenum down to the bone level and suturing by achieving primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Frenotomy procedure | Experimental | Two C-shaped partial thickness incisions are performed on the two sides of the frenum leaving the underlying periosteum intact. Relocation of the muscle attachment is performed by blunt dissection using a mucoperiosteal elevator. Undermining or separation of the epithelium from the underlying lip mucosa is then performed by blunt dissection to facilitate tension-free suturing. The epithelium is then sutured to the underlying periosteum using three interrupted periosteal sutures and is left to heal by secondary intention. Receives: Procedure: Frenotomy |
| Frenectomy procedure | Active comparator | Frenectomy group (Control): Two full-thickness incisions are performed apical and coronal to the frenum attachment and extending down to and including the periosteum. Complete excision of all muscle tissues is ensured and then both epithelial edges are approximated using single interrupted sutures achieving primary closure. Receives: Procedure: Frenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound / Relapse.
The level of the frenum will be measured at baseline and follow-up using William's graduated periodontal probe. The incisal edge will be assigned as a reference point at baseline to measure the frenum level before and after the procedure and identify the change in level.
Measured: 6 months
Secondary outcomes (1)
Postoperative pain
A visual analog scale (VAS) will be recorded by the patients during the first week postoperatively to compare the postoperative pain experienced after both procedures.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start20 Mar 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Frenum AttachmentStudies 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
- Randomized clinical trial. Allocation Ratio: 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Zazou, October University for Modern Sciences and Arts
- Investigators
- Nada Zazou, PHD, Principal investigator, Modern Sciences & Arts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331325
- Sponsor's protocol ID
- 724
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, Statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Frenotomy and Frenectomy Surgical Techniques for Management of High Frenum Attachment in Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06331325
- Acronym / sponsor ID
- 724
- Conditions
- High Frenum Attachment
- Keywords
- frenum, labial, frenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 26 Mar 2024 (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 compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:
- Does Frenotomy procedure have a lower relapse rate compared to frenectomy?
- Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week.
Detailed description
Frenum is a triangular thin folded mucus membrane with underlying connective tissue and muscular fibers that attaches the lips and cheeks with alveolar mucosa enhancing the stability of the lip (Newman et al., 2020).
High frenum attachment can have numerous negative effects when highly attached close to the gingival margin including gingival recession, papilla loss, and obliteration of the sulcus, which might enhance plaque accumulation indirectly by hindering tooth brushing. It may also be responsible for midline diastema (Miller, 1985).
According to Mirko et al. (1974), there are four different types of labial frenal attachments: mucosal, gingival, papillary, and papilla piercing. The mucosal form is the most common and predominates in the mandible (Jańczuk \& Banach, 1980).
Frenectomy procedure involves the complete removal of the frenum along with its attachment to the underlying bone. Frenotomy procedure is the incision and relocation of the frenal attachments to a more apical level (Dibart \& Karima, 2008). However, this procedure is not well-documented in the literature and little is known about its expected relapse rates.
The rationale for conducting the research:
The traditional frenectomy procedure as described by Archer (1961) and Kruger (1964) could be considered invasive and may lead to scarring, delayed healing, and loss of the interdental papilla due to bone exposure and complete removal of fibers which may have negative esthetic outcome in addition to the frequent relapse rate (Devishree et al., 2012). A systematic review (Delli et al., 2013) discussed some complications that may arise when performing frenectomy procedure such as scar formation, postoperative pain, and swelling. Thus, frenectomy is considered a radical procedure with potential complications.
In contrast, frenotomy could be introduced as a more conservative procedure that can achieve the same outcomes with lower postoperative complications and scar formation. To the best of our knowledge, no studies are comparing both techniques in terms of relapse rate and postoperative pain.
Thus, the rationale of our study is to evaluate the clinical effectiveness of frenotomy procedure and its effect on frenum relapse and postoperative pain compared to the conventional frenectomy procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial. Allocation Ratio: 1:1
| Arm | Type | Receives |
|---|---|---|
| Frenotomy procedure | Experimental | Procedure: FrenotomyTwo C-shaped partial thickness incisions are performed on the two sides of the frenum leaving the underlying periosteum intact. Relocation of the muscle attachment is performed by blunt dissection using a mucoperiosteal elevator. Undermining or separation of the epithelium from the underlying lip mucosa is then performed by blunt dissection to facilitate tension-free suturing. The epithelium is then sutured to the underlying periosteum using three interrupted periosteal sutures and is left to heal by secondary intention. |
| Frenectomy procedure | Active comparator | Procedure: FrenectomyFrenectomy group (Control): Two full-thickness incisions are performed apical and coronal to the frenum attachment and extending down to and including the periosteum. Complete excision of all muscle tissues is ensured and then both epithelial edges are approximated using single interrupted sutures achieving primary closure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults with active highly attached maxillary/mandibular labial frenum.
- Systemically healthy
- Non-smokers
- Gingival and plaque index <10%
Key exclusion criteria (5 listed)
- Poor oral hygiene.
- Smokers
- Any systemic diseases or medications that delay wound healing.
- Pregnant or lactating females
- Previous frenal procedures.
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 |
|---|---|---|
| FrenotomyAlso: Frenal relocationPartial thickness procedure aiming to relocate high frenum attachment to a more apical level. | Procedure or surgery | Frenotomy procedure |
| FrenectomyFull-thickness excision of the frenum down to the bone level and suturing by achieving primary closure. | Procedure or surgery | Frenectomy procedure |
Primary outcome
Rebound / Relapse.
Time frame: 6 months
The level of the frenum will be measured at baseline and follow-up using William's graduated periodontal probe. The incisal edge will be assigned as a reference point at baseline to measure the frenum level before and after the procedure and identify the change in level.
1 secondary outcome
Postoperative pain
Time frame: 1 week
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. Study protocol, Statistical analysis.
Related trials for High Frenum Attachment
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.
Nada Zazou, PHD principal investigator
Modern Sciences & Arts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frenotomy and Frenectomy in people with High Frenum Attachment, run by October University for Modern Sciences and Arts 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 4 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: finished, as of the sponsor's last update on 20 Jan 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?
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?
Rebound / Relapse. (time frame: 6 months). 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 20 Jan 2026.