---
title: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
nct_id: NCT02918344
overall_status: COMPLETED
sponsor: Universitair Ziekenhuis Brussel
study_type: OBSERVATIONAL
primary_condition: Jaw Anomalies
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02918344.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02918344"
ct_last_update_post_date: 2025-12-18
last_seen_at: "2026-05-12T07:22:24.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies

**Official Title:** Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies

**NCT ID:** [NCT02918344](https://clinicaltrials.gov/study/NCT02918344)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 196
- **Lead Sponsor:** Universitair Ziekenhuis Brussel
- **Conditions:** Jaw Anomalies, Infection
- **Start Date:** 2017-03-01
- **Completion Date:** 2020-04-30
- **CT.gov Last Update:** 2025-12-18

## Brief Summary

The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal.

An evaluation will be made to determine if the benefits of the use of the paste (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the disadvantages.

## Detailed Description

The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. Correction of distocclusion can be achieved through lengthening of the mandible, and a balanced facial appearance can be obtained by increasing chin projection.

Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border(1)(2) and to help stabilize the segments when osteosynthesis slippage is feared for. A recently performed retrospective study showed an increase of infectious complications when calcium phosphate paste was used for this indications. Several precautions were identified that could be undertaken to decrease the infectious complications. The study concluded that a prospective study was required in which these precautions were implemented to determine whether infectious complications can be reduced.

The aim of this study is to investigate whether the hardened paste still increases the incidence of site infections after implementation of several precautions and the use of a standardized antibiotic prophylactic protocol.

## Eligibility

- **Minimum age:** 15 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All patients with dysgnatic deformities requiring mandibular lengthening surgery
* Gender: M/F
* Age: \>15y-75y

Exclusion Criteria:

* Previous orthognathic surgery
* Congenital facial malformations
* Unilateral SSO
* Immunodeficiency
* Simultaneous removal of lower third molars
* Incomplete postoperative follow-up
```

## Arms

- **Standard sagittal split osteotomy group** — Patients undergoing sagittal split osteotomy without paste application
- **Cohort/Hydroset group** — Patients undergoing sagittal split osteotomy with paste application

## Interventions

- **Hydroset** (OTHER) — Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border and to help stabilize the segments when osteosynthesis slippage is feared for.
- **Standard sagittal split osteotomy** (PROCEDURE) — The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.

## Primary Outcomes

- **Surgical site infection** _(time frame: 6 months)_ — Determine the number of surgical site infection

## Secondary Outcomes

- **Hardware removal** _(time frame: 6 months)_
- **Revision** _(time frame: 6 months)_

## Locations (1)

- universitair Ziekenhuis brussel, Jette, Brussels Capital, Belgium

## 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.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — 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.universitair ziekenhuis brussel|jette|brussels capital|belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02918344.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02918344*  
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