PeriodontitisNIPSAGRAFTNCT04712630
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
A study testing Non-incised papila surgical approach without grafting biomaterial and Non-incised papila surgical approach with grafting biomaterial in people with Periodontitis and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
Trial summary
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- What is being tested?
- Non-incised papila surgical approach without grafting biomaterial and Non-incised papila surgical approach with grafting biomaterial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2019to 30 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with periodontitis.
- plaque index and bleeding index of < 30%.
- periodontal lesions with pocket probing depth > 5 mm.
- intrabony defect > 3 mm.
- intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
Who cannot join
- patients with systemic diseases that contraindicated treatment.
- third molars.
- teeth with incorrect endodontic or restorative treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.
- Being tested
- Non-incised papila surgical approach without grafting biomaterial, Non-incised papila surgical approach with grafting biomaterial
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-incised papila surgical approach without grafting biomaterialProcedure or surgery
Periodontal reconstructive surgery
Non-incised papila surgical approach with grafting biomaterialProcedure or surgery
Periodontal reconstructive surgery
| Study group | Role | What they receive |
|---|---|---|
| NIPSA without grafting biomaterial | Experimental | A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. Receives: Procedure: Non-incised papila surgical approach without grafting biomaterial |
| NIPSA with grafting biomaterial | Active comparator | A single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied and the bone defect will be filled with a composite of xenograft and enamel matrix derivates. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. Receives: Procedure: Non-incised papila surgical approach with grafting biomaterial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PD)
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Measured: 12 months
Clinical attachment level (CAL)
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Measured: 12 months
Recession (REC)
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Measured: 12 months
Location of the tip of the papillae (TP)
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.
This outcome will be assessed with a periodontal probe and measured in mm.
Measured: 12 months
Keratinized tissue width (KT)
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Measured: 12 months
Bleeding on probing
Bleeding on probing could be positive or negative.
Measured: 12 months
Secondary outcomes (2)
Supra-alveolar attachment gain (SUPRA-AG)
Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.
Measured: 12 months
Wound closure (WC)
Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start9 Sep 2019
- Primary completion9 Sep 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio José Ortiz Ruiz, MD, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712630
- Sponsor's protocol ID
- 2441/2019
- Acronym
- NIPSAGRAFT
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195.
PubMed 30118534Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
PubMed 30421495Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
PubMed 31190409Moreno Rodriguez JA, Ortiz Ruiz AJ. Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial. Clin Oral Investig. 2022 Mar;26(3):2793-2805. doi: 10.1007/s00784-021-04256-1. Epub 2021 Nov 17.
PubMed 34791548
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04712630
- Acronym / sponsor ID
- NIPSAGRAFT / 2441/2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 15 Jan 2021 (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.
This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.
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 without grafting biomaterial | Experimental | Procedure: Non-incised papila surgical approach without grafting biomaterialA single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. |
| NIPSA with grafting biomaterial | Active comparator | Procedure: Non-incised papila surgical approach with grafting biomaterialA single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied and the bone defect will be filled with a composite of xenograft and enamel matrix derivates. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients diagnosed with periodontitis.
- plaque index and bleeding index of < 30%.
- periodontal lesions with pocket probing depth > 5 mm.
- intrabony defect > 3 mm.
- intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
Key exclusion criteria (3 listed)
- patients with systemic diseases that contraindicated treatment.
- third molars.
- 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 without grafting biomaterialPeriodontal reconstructive surgery | Procedure or surgery | NIPSA without grafting biomaterial |
| Non-incised papila surgical approach with grafting biomaterialPeriodontal reconstructive surgery | Procedure or surgery | NIPSA with grafting biomaterial |
Primary outcome
Probing pocket depth (PD)
Time frame: 12 months
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Clinical attachment level (CAL)
Time frame: 12 months
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Recession (REC)
Time frame: 12 months
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Location of the tip of the papillae (TP)
Time frame: 12 months
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm.
Keratinized tissue width (KT)
Time frame: 12 months
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Bleeding on probing
Time frame: 12 months
Bleeding on probing could be positive or negative.
2 secondary outcomes
Supra-alveolar attachment gain (SUPRA-AG)
Time frame: 12 months
Wound closure (WC)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 30118534Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195.
- Background: PubMed 30421495Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
- Background: PubMed 31190409Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
- Derived from this study: PubMed 34791548Moreno Rodriguez JA, Ortiz Ruiz AJ. Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial. Clin Oral Investig. 2022 Mar;26(3):2793-2805. doi: 10.1007/s00784-021-04256-1. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
The record lists no contact. Use the official record to reach the sponsor.
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 without grafting biomaterial and Non-incised papila surgical approach with grafting biomaterial in people with Periodontitis and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 15 Jan 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pocket depth (PD) (time frame: 12 months). The study lists 6 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 NCT04712630, which also lists 4 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 15 Jan 2021.