Periodontal Attachment LossNCT06003322
Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect
A study testing non - Incised Papilla surgical approach NIPSA for intrabony defect and single-flap approach SFA in people with Periodontal Attachment Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Attachment Loss
- What is being tested?
- non - Incised Papilla surgical approach NIPSA for intrabony defect and single-flap approach SFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Aug 2023to 7 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Age > 18 years
- Diagnosis with stage III-IV periodontitis.
- Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth).
- No relevant systemic condition or disease.
Who cannot join
- Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry ,Assiut university
Asyut, 23145
Alaa Ali, Ph.D., 01003646556, alaa.ali@dent.aun.edu.eg
Aya Ali, Ph.D.
About this study
Official title: Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial
The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.
Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)
Read the detailed description
The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.
Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)
- Conditions
- Periodontal Attachment Loss
- Being tested
- non - Incised Papilla surgical approach NIPSA for intrabony defect, single-flap approach SFA
- Medical subject headings
- Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non - Incised Papilla surgical approach NIPSA for intrabony defectProcedure or surgery
As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues.
Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss
single-flap approach SFAProcedure or surgery
As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding).
-A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture
| Study group | Role | What they receive |
|---|---|---|
| non - Incised Papilla surgical approach NIPSA for intrabony defect | Experimental | Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF Receives: Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defect |
| single-flap approach | Active comparator | group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF Receives: Procedure: single-flap approach SFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
interproximal clinical attachment level change
CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe
Measured: at baseline ,6 and 12 months
Secondary outcomes (1)
residual probing pocket depth (PPD), pocket depth (PD) change,
-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe
Measured: at at baseline ,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start7 Aug 2023
- Primary completion7 Aug 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Attachment LossStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University, Egyptian Russian University
- Responsible party
- Principal investigator, Alaa Talaat Ali, Ain Shams University
- Investigators
- ALAA T ALI, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003322
- Sponsor's protocol ID
- PER243
- Status last verified
- Aug 2023
- First submitted
- 24 Jun 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06003322
- Acronym / sponsor ID
- PER243
- Conditions
- Periodontal Attachment Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University, Egyptian Russian University
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 21 Aug 2023 (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 present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.
Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)
Detailed description
The present study will aim to assess the effectiveness of the non-Incised Papilla surgical approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the single-flap approach SFA.
Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar attachment gain (SUPRA-AG)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non - Incised Papilla surgical approach NIPSA for intrabony defect | Experimental | Procedure: non - Incised Papilla surgical approach NIPSA for intrabony defectGroup I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF |
| single-flap approach | Active comparator | Procedure: single-flap approach SFAgroup II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Age > 18 years
- Diagnosis with stage III-IV periodontitis.
- Presence of one or more intrabony defects with probing pocket depth (PPD) > 5 mm and radiographic defect depth > 4 mm.
- Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 30% (measured at four sites per tooth).
- No relevant systemic condition or disease.
Key exclusion criteria (2 listed)
- Third molars and teeth with type III mobility or with an incorrect endodontic or restorative treatment.
- -
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 |
|---|---|---|
| non - Incised Papilla surgical approach NIPSA for intrabony defectAs described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues. Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss | Procedure or surgery | non - Incised Papilla surgical approach NIPSA for intrabony defect |
| single-flap approach SFAAs described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding). -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture | Procedure or surgery | single-flap approach |
Primary outcome
interproximal clinical attachment level change
Time frame: at baseline ,6 and 12 months
CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe
1 secondary outcome
residual probing pocket depth (PPD), pocket depth (PD) change,
Time frame: at at baseline ,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Periodontal Attachment Loss
Recruiting
Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction
Alveolar Bone Loss, Periodontal Pocket
Recruiting
PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy
Periodontitis, Periodontal Inflammation
Recruiting
Hyaluronic Acid and Polynucleotides for Supra-bony Defects
Periodontal Diseases, Wound Heal
Recruiting
Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects
Periodontal Diseases, Periodontal Attachment Loss
Active, not recruitingObservational study
Evaluation of OHIP-14 and OSHIP-14 in Patients With Varying Periodontal Disease
Periodontal Disease
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.
ALAA T ALI, PhD study director
Assiut 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 non - Incised Papilla surgical approach NIPSA for intrabony defect and single-flap approach SFA in people with Periodontal Attachment Loss, run by Ain Shams University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Ali, P.h.D (01003646556, alaa.ali@dent.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interproximal clinical attachment level change (time frame: at baseline ,6 and 12 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 21 Aug 2023.