---
title: Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.
nct_id: NCT03584906
overall_status: COMPLETED
phase: NA
sponsor: University of Milan
study_type: INTERVENTIONAL
primary_condition: Gingival Recession
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03584906.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03584906"
ct_last_update_post_date: 2020-06-30
last_seen_at: "2026-05-12T07:28:25.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

**Official Title:** Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study

**NCT ID:** [NCT03584906](https://clinicaltrials.gov/study/NCT03584906)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** University of Milan
- **Conditions:** Gingival Recession, Palate; Wound
- **Start Date:** 2018-08-16
- **Completion Date:** 2020-06-15
- **CT.gov Last Update:** 2020-06-30

## Brief Summary

The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

## Detailed Description

The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft.

The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 18 years of age or greater,
* Patients with no reported systemic diseases,
* Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy,
* Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of \< 15%,
* Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth
* No history of previous palatal harvesting

Exclusion Criteria:

* Pregnancy
* Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c \> 7%, INR \> 3 etc.)
* Non-compensated systemic disease
* Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) \> 20% at baseline
* Inadequate endodontic treatment or tooth mobility at the site of surgery
* Radiographic evidence of bone loss
```

## Arms

- **De-epithelialized gingival graft (DGG)** (EXPERIMENTAL) — A harvesting approach where the a graft is obtained from the superficial palate and then extra-orally de-epithelialized in order to obtain a connective tissue graft (DGG harvesting approach) Then the DGG is used for treating gingival recessions (root coverage procedure)
- **Envelope technique (ET)** (EXPERIMENTAL) — A harvesting approach where only one horizontal incision is performed on the palate (ET harvesting approach) for harvesting a connective tissue graft.

Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)
- **Trap door technique (TDT)** (EXPERIMENTAL) — A harvesting approach where one horizontal and two vertical incisions are performed on the palate (TDT harvesting approach) for harvesting a connective tissue graft.

Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)
- **Maxillary tuberosity (MT)** (EXPERIMENTAL) — A harvesting approach that obtains an epithelialized gingival graft from the maxillary tuberosity (MT harvesting approach) which is then extra-orally de-epithelialized in order to obtain a connective tissue graft.

Then the connective tissue graft is used for treating gingival recessions (root coverage procedure)

## Interventions

- **DGG Harvesting approach** (PROCEDURE) — An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
- **ET harvesting approach** (PROCEDURE) — A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
- **TDT harvesting approach** (PROCEDURE) — A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
- **MT harvesting approach** (PROCEDURE) — An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
- **Root coverage procedure** (PROCEDURE) — A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

## Primary Outcomes

- **Patient morbidity (VAS)** _(time frame: 14 days)_ — Patient post-operative pain measured using a VAS scale
- **Mean root coverage (mRC)** _(time frame: 6 months)_ — mRC measured as a percentage

## Secondary Outcomes

- **Clinical attachment level (CAL) gain** _(time frame: 6 months)_
- **Gingival thickness (GT)** _(time frame: 6 months)_
- **Patient willingness for retreatment** _(time frame: 14 days)_
- **Painkillers consumption** _(time frame: 14 days)_
- **Root coverage Esthetic Score (RES)** _(time frame: 6 months)_
- **Keratinized tissue (KT) gain** _(time frame: 6 months)_

## Locations (2)

- University of Milan, Milan, Italy
- Studio Odontoiatrico, Piacenza, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of milan|milan||italy` — added _(2026-05-12)_
- `locations.studio odontoiatrico|piacenza||italy` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT03584906.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03584906*  
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