Periodontal Intrabony DefectNCT06687785
Entire Papilla Preservation and Conventional Flap Surgery in Treating Intrabony Defects: A 6-Month Clinical Trial
An observational study of Periodontal Intrabony Defect, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Intrabony Defect
- What is being tested?
- Entire Papilla Preservation Technique and Conventional Flap Surgery Technique
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2024to Feb 2025
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Periodontitis patients with isolated intrabony defects
Who may be able to join
- Systemic health
- Probing depth (PD) ≥7 mm
- Clinical attachment level (CAL) ≥7 mm
- Presence of an isolated two or three walled intraosseous defect with an intraosseous component of at least 4 mm predominantly involving the interproximal region of the affected tooth
- Full mouth plaque score (FMPS) and full mouth bleeding score ≤20%
Who cannot join
- Current smoking habit
- Presence of uncontrolled systemic diseases that prevent periodontal surgery
- Use of drugs that affect periodontal tissues
- Pregnancy and breastfeeding
- Single-walled intraosseous defects
- Defects involving the buccal and/or lingual areas of the tooth
- Inadequate endodontic treatment and/or restorations on teeth in the defect area.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Dentistry
Konya
About this study
Official title: A Comparison of the Clinical and Radiographic Results of the Entire Papilla Preservation (EPP) Technique and Conventional Flap Surgery (CFS) Technique in the Treatment of Isolated Intrabony Defects at 6 Months
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.
- Conditions
- Periodontal Intrabony Defect
- Being tested
- Entire Papilla Preservation Technique, Conventional Flap Surgery Technique
- Keywords
- intrabony defect, conventional flap surgery, bone graft, entire papilla preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire Papilla Preservation TechniqueProcedure or surgery
Also called EPP
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.
Conventional Flap Surgery TechniqueProcedure or surgery
Also called CFS
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.
| Study group | Role | What they receive |
|---|---|---|
| Entire Papilla Preservation Technique | 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 Receives: Procedure: Entire Papilla Preservation Technique | |
| Conventional Flap Surgery | 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. Receives: Procedure: Conventional Flap Surgery Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 MONTH
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start26 Jul 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal Intrabony DefectStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uçan Yarkaç, Necmettin Erbakan University
- Investigators
- Fatma UCAN YARKAC, assoc. prof., Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687785
- Sponsor's protocol ID
- 20576
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stavropoulos A, Karring T. Five-year results of guided tissue regeneration in combination with deproteinized bovine bone (Bio-Oss) in the treatment of intrabony periodontal defects: a case series report. Clin Oral Investig. 2005 Dec;9(4):271-7. doi: 10.1007/s00784-005-0002-7. Epub 2005 Jul 12.
PubMed 16010581Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.
PubMed 28196163Yarkac FU, Yildiz K, Kalender ME, Ogutcen O. Clinical and radiographic outcomes of entire papilla preservation versus open flap debridement using bovine-derived xenograft and leukocyte- and platelet-rich fibrin in the treatment of isolated intrabony defects. BMC Oral Health. 2025 Oct 21;25(1):1639. doi: 10.1186/s12903-025-07008-9.
PubMed 41121124
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Clinical and Radiographic Results of the Entire Papilla Preservation (EPP) Technique and Conventional Flap Surgery (CFS) Technique in the Treatment of Isolated Intrabony Defects at 6 Months
- ClinicalTrials.gov ID
- NCT06687785
- Acronym / sponsor ID
- 20576
- Conditions
- Periodontal Intrabony Defect
- Keywords
- intrabony defect, conventional flap surgery, bone graft, entire papilla preservation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 14 Nov 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entire Papilla Preservation Technique | – | Procedure: Entire Papilla Preservation TechniqueThe 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 |
| Conventional Flap Surgery | – | Procedure: Conventional Flap Surgery TechniqueIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontitis patients with isolated intrabony defects
Key inclusion criteria (5 listed)
- Systemic health
- Probing depth (PD) ≥7 mm
- Clinical attachment level (CAL) ≥7 mm
- Presence of an isolated two or three walled intraosseous defect with an intraosseous component of at least 4 mm predominantly involving the interproximal region of the affected tooth
- Full mouth plaque score (FMPS) and full mouth bleeding score ≤20%
Key exclusion criteria (7 listed)
- Current smoking habit
- Presence of uncontrolled systemic diseases that prevent periodontal surgery
- Use of drugs that affect periodontal tissues
- Pregnancy and breastfeeding
- Single-walled intraosseous defects
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 |
|---|---|---|
| Entire Papilla Preservation TechniqueAlso: EPPA 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. | Procedure or surgery | Entire Papilla Preservation Technique |
| Conventional Flap Surgery TechniqueAlso: CFSAfter 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. | Procedure or surgery | Conventional Flap Surgery |
Primary outcome
Probing Depth
Time frame: 6 MONTH
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.
Clinical Attachment Level
Time frame: 6 MONTH
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.
Gingival Recession
Time frame: 6 MONTH
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.
2 secondary outcomes
Visual analogue scale
Time frame: for 2 weeks after treatment
Early healing index.
Time frame: 1 week after treatment
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 27 Dec 2024.
- Results publication: PubMed 16010581Stavropoulos A, Karring T. Five-year results of guided tissue regeneration in combination with deproteinized bovine bone (Bio-Oss) in the treatment of intrabony periodontal defects: a case series report. Clin Oral Investig. 2005 Dec;9(4):271-7. doi: 10.1007/s00784-005-0002-7. Epub 2005 Jul 12.
- Results publication: PubMed 28196163Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.
- Derived from this study: PubMed 41121124Yarkac FU, Yildiz K, Kalender ME, Ogutcen O. Clinical and radiographic outcomes of entire papilla preservation versus open flap debridement using bovine-derived xenograft and leukocyte- and platelet-rich fibrin in the treatment of isolated intrabony defects. BMC Oral Health. 2025 Oct 21;25(1):1639. doi: 10.1186/s12903-025-07008-9.
- 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.
Fatma UCAN YARKAC, assoc. prof. principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Intrabony Defect, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 7 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 27 Dec 2024. 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 Turkey (Türkiye). 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?
Probing Depth (time frame: 6 MONTH). 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?
On the ClinicalTrials.gov record for NCT06687785, which also lists 3 linked publications.
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 27 Dec 2024.