PeriodontitisNCT05864989
Non-Incised Papilla Flap in Deep Supraossous Defects
A study testing Non-incised papila surgical approach only and Non-incised papila surgical approach with connective tissue grafting in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-incised papila surgical approach only and Non-incised papila surgical approach with connective tissue grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Nov 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- diagnosis of periodontal disease (periodontitis stage III and IV, grade A [12];
- non-smokers and former smokers who quit smoking at least 1 year previously
- previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
- compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
- active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
- periodontal lesions with probing depth (PD) > 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe)
Who cannot join
- systemic disease contraindicating periodontal surgery,
- smokers, and
- third molars or teeth with incorrect
- endodontic or restorative treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University- Russian University in Egypt
Cairo, Cairo Governorate, 11566
Mahetab mohamed A Wahab, PhD, 01115554490, mahetabmohamed@dent.asu.edu.eg
Mahetab mohamed A Wahab, 01005251611, mahetabmohamed@dent.asu.edu.eg
About this study
Official title: Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects
The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.
The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .
- Conditions
- Periodontitis
- Being tested
- Non-incised papila surgical approach only, Non-incised papila surgical approach with connective tissue grafting
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-incised papila surgical approach onlyProcedure or surgery
Reconstructive periodontal surgery
Non-incised papila surgical approach with connective tissue graftingProcedure or surgery
Reconstructive periodontal surgery
| Study group | Role | What they receive |
|---|---|---|
| NIPSA in deep supra-alveolar defects without connective tissue graft | Experimental | Not described Receives: Procedure: Non-incised papila surgical approach only |
| NIPSA in deep supra-alveolar defects with connective tissue graft | Active comparator | Not described Receives: Procedure: Non-incised papila surgical approach with connective tissue grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
interproximal clinical attachment level gain
measured from CEJ to base of pocket depth by using periodontal prob
Measured: 6 MONTHS
Secondary outcomes (1)
residual pocket depth
distance from gingival margin to pocket depth by using periodontal prob
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahetab mohamed abdel el wahab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864989
- Sponsor's protocol ID
- 1240
- Status last verified
- May 2024
- First submitted
- 1 May 2023
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-Incised Papilla Flap
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Incised Papilla Flap With and Without Connective Tissue Graft for Management of Deep Supraossous Defects
- ClinicalTrials.gov ID
- NCT05864989
- Acronym / sponsor ID
- 1240
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 18 May 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 objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.
The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPSA in deep supra-alveolar defects without connective tissue graft | Experimental | Procedure: Non-incised papila surgical approach only |
| NIPSA in deep supra-alveolar defects with connective tissue graft | Active comparator | Procedure: Non-incised papila surgical approach with connective tissue grafting |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of periodontal disease (periodontitis stage III and IV, grade A [12];
- non-smokers and former smokers who quit smoking at least 1 year previously
- previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
- compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
- active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
Key exclusion criteria (4 listed)
- systemic disease contraindicating periodontal surgery,
- smokers, and
- third molars or teeth with 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 papila surgical approach onlyReconstructive periodontal surgery | Procedure or surgery | NIPSA in deep supra-alveolar defects without connective tissue graft |
| Non-incised papila surgical approach with connective tissue graftingReconstructive periodontal surgery | Procedure or surgery | NIPSA in deep supra-alveolar defects with connective tissue graft |
Primary outcome
interproximal clinical attachment level gain
Time frame: 6 MONTHS
measured from CEJ to base of pocket depth by using periodontal prob
1 secondary outcome
residual pocket depth
Time frame: 6 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. Non-Incised Papilla Flap
Related trials for Periodontitis
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Recruiting
Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
Periodontitis, Periodontal Diseases
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study
Periodontitis (Stage 3), Periodontitis Stage IV
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.
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 papila surgical approach only and Non-incised papila surgical approach with connective tissue grafting in people with Periodontitis, 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 6 inclusion and 4 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 30 May 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 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 Mahetab mohamed A Wahab, PhD (01115554490, mahetabmohamed@dent.asu.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 gain (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 30 May 2024.