## Protocol Section
### Identification Module
**NCT ID:** NCT06428149

**Brief Title:** Three Types of Papilla Incision in Periodontal Surgery

**Official Title:** Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. A Randomized Clinical Trial

#### Organization Study ID Info
**ID:** 2937/2020
#### Organization
**Class:** OTHER
**Full Name:** Universidad de Murcia
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad de Murcia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Three types of papilla incision in periodontal reconstruction techniques will be compared.

### Conditions Module

**Conditions:**

- Periodontitis

- Periodontal Diseases

- Periodontal Pocket

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.

**Intervention Names:**

- Procedure: Midline interproximal soft-tissue incision

**Label:** Midline interproximal soft-tissue incision

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces.

**Intervention Names:**

- Procedure: Marginal approach by palatal incision

**Label:** Marginal approach by palatal incision

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures.

**Intervention Names:**

- Procedure: Minimally invasive surgical technique

**Label:** Minimally invasive surgical technique

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Midline interproximal soft-tissue incision

**Description:** Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth.

**Name:** Midline interproximal soft-tissue incision

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Marginal approach by palatal incision

**Description:** First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed.

**Name:** Marginal approach by palatal incision

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Minimally invasive surgical technique

**Description:** The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine.

**Name:** Minimally invasive surgical technique

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Bleeding on probing could be positive or negative

**Measure:** Bleeding on probing

**Time Frame:** 12 months

**Description:** Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket

**Measure:** Clinical attachment level (CAL)

**Time Frame:** 12 months

**Description:** Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket

**Measure:** Probing pocket depth (PD)

**Time Frame:** 12 months

**Description:** Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

**Measure:** Recession (REC)

**Time Frame:** 12 months

**Description:** 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.

**Measure:** Location of the tip of the papillae (TP)

**Time Frame:** 12 months

**Description:** 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.

**Measure:** Keratinized tissue width (KT)

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result.

**Measure:** Supra-alveolar attachment gain (SUPRA-AG)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients diagnosed with periodontal disease.
* Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance.
* Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm.
* Plaque index and bleeding index less than 30%.

Exclusion Criteria:

* Systemic disease that contraindicates periodontal surgery.
* Pregnant women.
* Third molars or teeth with incorrect endodontic or restorative treatment.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ajortiz@um.es

**Name:** ANTONIO J ORTIZ-RUIZ, MD

**Phone:** +34 868888581

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Murcia

**Contacts:**

***Contact 1:***

- **Name:** JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS

- **Phone:** +34 620538483

- **Role:** CONTACT

**Country:** Spain

**Facility:** Centro Odontologico Del Sureste Slp

**Status:** RECRUITING

**Zip:** 30007

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M13423

- Name: Periodontal Pocket

- Relevance: HIGH

- As Found: Periodontal Pocket

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: HIGH

- As Found: Periodontal Diseases

- ID: M1112

- Name: Surgical Wound

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000010514

- Term: Periodontal Pocket

### Misc Info Module

- Version Holder: 2024-05-31
