An observational study in Periodontal Intrabony Defect, sponsored by Necmettin Erbakan University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Necmettin Erbakan University · Observational
Intraosseous defects are characterized by vertical bone loss within the borders of the alveolar bone surrounding the teeth due to periodontal disease and are considered a clinically concerning condition. Treatment of intraosseous defects involves regenerative techniques aimed at reconstructing lost periodontal structures (including bone, cementum and periodontal ligament). In the process of periodontal regeneration, it is of great importance that the blood clot attached to the root surface is protected from mechanical and microbiological factors and remains in a stable biological environment. Post-surgical wound dehiscence can lead to impaired clot stabilization and infection, negatively affecting the healing process and thus jeopardizing the results of the treatment.
Regenerative therapies using conventional flap surgery have been reported to provide significant improvements in clinical attachment levels, but carry a high risk of loss of attachment if flap management is inadequate. Furthermore, complications such as difficulty in primary closure, risk of membrane exposure and tissue detachment have been observed with conventional flap techniques. Various minimally invasive flap surgery techniques have been developed to prevent these complications. One of the minimally invasive periodontal flap techniques is the full papillary preservation technique. Unlike traditional methods, this innovative approach provides vertical access to the defect area from the buccal and lingual adjacent areas without any incision in the papillary region. This technique reduces the risk of wound healing failure and exposure of regenerative biomaterials due to the fully preserved interdental papilla over the bony defect. The aim of our study is to compare the short-term (6 months) radiographic and clinical results of the Entire Papilla Preservation (EPP) technique with the Conventional Flap Surgery (CFS) technique.
Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.
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Periodontitis patients with isolated intrabony defects
Exclusion Criteria:
The Entire Papilla Preservation Technique (EPP) is a novel surgical approach aimed at enhancing periodontal regeneration, particularly in the treatment of deep intrabony defects. This technique is characterized by its focus on preserving the entire interdental papilla, which is crucial for both functional and aesthetic outcomes in periodontal therapy. The EPP technique involves creating a tunnel-like undermining incision that allows access to the defect while maintaining the integrity of the papilla, thereby minimizing trauma to the surrounding soft tissues
Procedure: Entire Papilla Preservation Technique
In periodontology, the traditional flap surgery technique is a well-established surgical approach used for the treatment of periodontal diseases, especially in cases with deep periodontal pockets. This technique involves the lifting of a mucoperiosteal flap in the buccal and lingual direction to gain access to the underlying periodontal tissues and allows for thorough debridement of root surfaces and removal of diseased tissue.
Procedure: Conventional Flap Surgery Technique
A buccal intrasulcular incision was made in the tooth with the defect and a vertical incision was made extending from the buccal center of the tooth to the mesial papillary crest and crossing the mucogingival line. Then, using a micro periosteal elevator, a full-thickness mucoperiosteal flap was lifted from the incision site to the defect under the papilla. After removal of the granulation tissues in the area, bone graft was applied for regenerative purposes and the vertical incision was sutured with 6/0 polypropylene suture using simple suture technique.
Also known as: EPP
After buccal and lingual intrasulcular incisions were made to eliminate the teeth and papillae adjacent to the defect, a full-thickness mucoperiosteal flap was raised in the vestibular and lingual direction with a periosteal elevator. After removal of the granulation tissues in the area, bone graft was applied for regenerative purposes and the papillary incisions were sutured with 5/0 polypropylene suture using simple suture technique.
Also known as: CFS
Probing Depth
Probing Depth (PD) refers to the distance from the gingival margin to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Time frame: 6 MONTH
Clinical Attachment Level
Clinical Attachment Level (CAL) is defined as the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. It is expressed in mm and a high measurement is a clinically unfavorable value.
Time frame: 6 MONTH
Gingival Recession
Gingival Recession (GR) refers to the apical migration of the gingival margin, resulting in exposure of the root surface. While it should be 0 in healthy individuals, an increase is a bad value.
Time frame: 6 MONTH
Visual analogue scale
Postoperative patients were asked to fill out a visual analogue scale to determine their pain levels on the 1st, 3rd, 7th and 14th days. This scale was scored between 0-100, with 0 indicating no pain and 100 indicating unbearable pain.
Time frame: for 2 weeks after treatment
Early healing index.
The healing status in the first postoperative week was evaluated with a score between 1(perfect healing) and 5(worst healing) using the early healing index.
Time frame: 1 week after treatment
Plan to share: No
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Necmettin Erbakan University