The Clinical Comparison of the Keratinized Tissue Gain in Frenal Relocation Alone to Frenal Relocation Combined With the Application of Free Gingival Graft in High Frenum Attachment: A Randomized Clinical Study
| Registry | NCT07854132, acronym Frenotomy/FGG |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 26 (Estimated) |
| Sponsor | October University for Modern Sciences and Arts (Other) |
| Conditions | Keratinized Tissue Gain |
| Interventions | Frenotomy, Frenotomy with Free Gingival Graft (Procedure) |
| Dates | start 2026-09-30 (estimated), primary completion 2027-05-30 (estimated), completion 2027-06-30 (estimated), first posted 2026-10-02, last updated 2026-10-02 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Keratinized Tissue Gain All trials of Frenotomy All trials of Frenotomy with Free Gingival Graft
The goal of this randomized clinical study is to compare in Adults Clinical Effect of Frenal Relocation without Free Gingival Graft Application on Keratinized Tissue Gain When Compared to Frenal Relocation with Free Gingival Graft Application. The main question aims to answer:
In Adults with high frenum attachment, will frenal relocation alone show a difference or enhance the keratinized tissue gain compared to frenal relocation procedure combined with the application of a free gingival graft?
Statement of the problem:
An active aberrant labial frenum could create in certain patients a functional and esthetic problem and a challenge for the dentist to treat. The aberrant labial frenum is active when it has an obvious active muscle pull seen in the movement of the interdental papilla between the central incisors, which may originate a serious harm to the gingival health that occurs when it is attached too closely to the free gingival margin leading to the advancement of the problem to an obvious complication.
When an aberrant labial frenal attachment is present, it may cause, by its fibrous attachment, a midline diastema or a flattened papilla creating an esthetic problem. The consequences of this high attachment will hinder the proper maintaining of a good oral hygiene by shallowing the vestibular depth in the area of high frenum attachment creating a functional problem.
The band of keratinized attached gingival tissue around teeth maintains the periodontal health and counteracts the progression of gingival recession, but with the difficulty in maintaining good oral hygiene by shallowing the vestibular depth in the area of high frenum attachment, it will cause the advancement of a gingival recession and decrease the zone of keratinized attached gingiva affecting the esthetics and functionality. The labial frenum in these cases, when it has an active muscle pull and is attached to the free gingival margin, is not anymore considered a normal physiological anatomy, it turned to a pathogenic condition and is indicated for correction of this pathogenic attachment and turn it to a more desirable position.
Correction of aberrant labial frenum could be done by certain surgical procedures as frenectomy, frenotomy or some technique modifications as the Miller's technique, V-Y plasty technique and Z-plasty technique, and they are accomplished either with conventional scalpel technique, electrosurgery or using lasers. A Free Gingival Graft with aberrant frenum correction procedure could be used for increasing the zone of keratinized tissue and stabilizing the frenum muscles but using FGG is accompanied by unfavorable consequences such as its morbidity, with a second surgical harvested site, and increase the risk for excessive post operative bleeding and infection and unavoidable post-operative added pain. In addition, the color of palatal tissues usually differs from the keratinized tissues in the recipient site resulting in color mismatch when harvesting a FGG in the defect area. The need of a second surgical site leads to another surgery that increases the procedure time. Therefore, all these complications may negatively interfere with patients quality of life and willingness to undergo this procedure or any other future ones.
Rationale for conducting the research:
Patients, who are seen with active aberrant frenum, may suffer and complain from its consequences as hypersensitivity and pain due to gingival recession and difficulty in oral hygiene control, also it may be accompanied with poor esthetics resulted due to the midline diastema. Therefore, this aberrant frenum has to be treated and reestablished to a more desirable position, and the normal gingival and periodontal structures have to be restored.
Frenectomy, which is the complete removal of the frenum underlying muscles including its bone attachment, would be considered the Gold Standard technique for treatment of high frenum attachment. But when compared to frenotomy technique, which is the apical repositioning of frenum attachment, it is more likely to induce more post-operative pain. Therefore, frenotomy technique would be a more favorable treatment option for cases of aberrant frenum.
For more predictable and reliable treatment outcomes, in order to correct the aberrant frenum attachment and to restore the affected gingival tissues including the net amount of keratinized zone, it is recommended to correct the frenum attachment in combination with a free gingival graft. Frenum attachment correction with free gingival graft seems a highly recommended option, but some patients hesitate to undergo this procedure as the graft has to be harvested from a second surgical site (e.g. the palate), which seems aggressive and painful to some of them.
Frenal relocation could have comparable results, when compared to the use of free gingival graft, in the keratinized tissue regain avoiding a second surgical site and unnecessary added pain to the main procedure. Therefore, frenotomy alone would be a desirable choice, as it is a simpler procedure than frenotomy with free gingival graft. So, the aim of our study is to compare frenotomy procedure alone to frenotomy with free gingival graft in terms of keratinized tissue gain and relapse rates of both procedures.
Review of literature:
The mucous membrane fold of the vestibule that encloses a fibrous band of muscle tissues and attaches the soft tissue of the labial mucosa to the bone of the mandible and the maxilla is defined as the "Frenum". It is usually found in the maxillary and mandibular vestibular alveolar mucosa and may be located at the midline area between the two central incisors labially and the canine premolar region buccally in the shape of a triangleshaped folds, which may be thin and long or broad and short.
The frenum, histologically, is composed of loose fibrous connective tissue with many elastic fibers that runs along a few striated muscle fibers and all structures are covered with the mucosal epithelial lining. This fibrous and muscular structure serves mainly in the stabilization of the loose mobile upper and lower lips which limits their movements. Normally, the frenum attachment is located at the mucogingival junction (or could be called a "mucosal attachment") that is a few millimeters far from the free gingival margin and separated by the attached gingiva, which is a dense, non-elastic lamina propria covered by a keratinized stratified squamous epithelium.
This frenum attachment has to be attached to its normal position, but variation of this attachment is inevitable and may be attached to different levels, which could be accompanied by certain consequences to the involved structures. This diversity in frenum attachment could be classified according to the morphologic changes of the frenum shape and the clinical presentation of the attachment location. Firstly, a classification of the frenum which is based on the morphotypes was introduced by Sewerin. Accordingly, the frenum could be described as simple frenum, persistent labial frenum, simple frenum with an appendix, simple frenum with a nodule, double frenum, frenum with niche, bifid frenum and frenum with two or more variations at the same time. Then, another classification, aimed to describe the clinical presentation of the frenum attachment location, was introduced and described by Mirko. The frenum attachment location could be classified as mucosal, gingival, papillary and papillary penetrating, where mucosal attachment means that the frenum fibrous bundle is inserted at the mucogingival junction level, gingival attachment means that the frenum fibrous bundle is inserted within the attached gingiva, papillary attachment means that the frenum fibrous bundle is inserted within the interproximal papilla and papillary penetrating means that the frenum fibrous bundle pass over the interproximal alveolar crestal bone toward the oral side of the interproximal papilla.
The deviation from the normal mucosal frenum attachment to any other variation will result in the development of undesirable frenum location which could be called "Aberrant Frenum", and the more coronally the frenum attachment level is located, the more severe the consequences will be. When the insertion points of the frenum involve the free gingival margin, problems start to appear in different aspects. The aberrant frenum attachment may become a pathogenic mucogingival condition that may create an esthetic problem presented as a midline diastema or a flattened papilla that appears as black triangles interproximally, or it also may create a functional problem by shallowing the vestibular depth at the area of frenum attachment that would hinder the proper cleansing and hygiene control. This coronal creeping of frenum attachment is developed in the expense of the amount of keratinized attached gingiva that reduce its width around teeth, which is responsible for protecting free gingival margin from any progression of gingival recession. Therefore, the detection and management of aberrant frenum has to be established as early as possible to clear the possibility of any worsening that might affect the involved tissues. To detect and diagnose an aberrant frenum, it can be visually detected by Blanching/Pull test, which is done by applying some sort of light tension over the frenum and inspect the tip of the papilla if there is any movement, or the blanching that appears due to ischemia in the area of high attachment. In addition, inspection of the involved tissues, as the base of the frenum that is inserted into the gingiva in the expense of the amount keratinized attached gingival tissues, is also evaluated.
To correct the aberrant frenum attachment, some surgical interventions are used including frenectomy, frenotomy or some modified techniques as the Miller's technique, V-Y plasty technique and Z-plasty technique, and they are accomplished either with conventional scalpel technique, electrosurgery or using lasers. Frenectomy, which is described as the complete removal of the enclosed muscles within the fibrous bundles with a full thickness removal till reaching the underlying bone, is considered the gold standard for the treatment of aberrant frenum attachment. Another choice for treatment of the aberrant frenum is called "frenotomy", but it was discussed briefly in the literature in some studies. Frenotomy is described as the vestibular apical repositioning or relocation of the frenal muscle attachment with split thickness incisions not reaching the underlying bone and leaving the periosteum intact.
The reduced amount of keratinized attached gingiva, which is affected from this pathogenic condition, should be regained to increase the stability and quality of attached gingiva and to resist any tendency for gingival recession progression. This could be achieved via surgical frenum correction combined with the application of a free gingival graft harvested from the palate. Recently some studies reported gain of keratinized tissue with apical relocation of the vestibule which is similar to frenal relocation procedures (frenotomy), as it was done by a vestibular deepening procedure with split thickness incisions and apically positioning of the muscle at the area of aberrant frenum resembling vestibuloplasty introduced previously in the literature by Lim and Lee. Therefore, the aim of our study is to evaluate the amount of keratinized tissue gain in high frenum attachment with frenotomy procedure alone in comparison to frenotomy combined with free gingival graft.
Explanation for choice of comparators:
The application of a free gingival graft is the well-proven, most recommended, and reliable procedure used for increasing the zone of keratinized tissue. It may provide some stability of the frenum to resist the reattachment and relapse.
But all drawbacks, as it includes its morbidity due to a second surgical site involvement, increased pain, graft color mismatching, increase procedure time and increase risk for post operative bleeding and infection, which antagonize the patient priorities, so if frenotomy can achieve comparable outcomes in terms of gaining keratinized tissue it will be more beneficial for the patient.
Patient comfort and satisfaction are of great importance in the management of the high frenum attachments as well as any surgical procedures. Frenotomy would be a simple, less morbidity and less-time consuming procedure when used as a treatment choice. Also, with its technique benefits of adding more amount of keratinized tissue.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Frenotomy | Experimental | Procedure: Frenotomy | 1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The epithelium will be sutured to the underlying periosteum using three interrupted periosteal 6-0 resorbable sutures and left to heal by secondary intention. |
| Frenotomy with Free Gingival Graft | Active comparator | Procedure: Frenotomy with Free Gingival Graft | 1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The desired size of the graft will be determined using a template and a free gingival graft will be harvested from the palate. 5. The graft will then be positioned and adapted firmly by suturing to the periosteum at the recipient site using 6-0 resorbable sutures. 6. The epithelium will be then sutured to the underlying periosteum using three interrupted periosteal 6-0 sutures and left to heal by secondary intention. |
Sex: All, ages: 18 Years to 50 Years
Inclusion Criteria: * Systemically healthy. * Good oral hygiene (Gingival and plaque index <20%) * Highly attached labial frenum. * Narrow sulcus depth. * Current smokers who smoke ≤10 cigarettes per day Exclusion Criteria: * Smokers who smoke >10 cigarettes per day. * Poor oral hygiene. * Patient with a physical disability that hinders the upkeep of good oral hygiene measures. * Any systemic diseases or taking any medications that could affect wound healing. * Periodontitis patients. * Previous frenal procedures. * Pregnant or lactating females. * Pervious periodontal surgery within the last 6 months before the start of the trial.
| Facility | City | Country | Status |
|---|---|---|---|
| October University for Modern Sciences and Arts | Giza | Egypt |