CompletedInterventional

The Scandcleft project

About one in every 500 to 600 babies is born with a cleft lip, palate, or both. For babies born with a complete cleft on one side, repairing the gap requires surgery during their first few years, followed by supportive care for speech and dental growth into their teenage years. Surgeons currently use slightly different timings and methods for these initial operations. The Scandcleft project is a major study comparing four established surgical schedules across cleft centres in the UK and Scandinavia. Babies in the trial have their lip and palate repaired in planned stages between 3 months and 3 years of age. Researchers closely track each child's healing, speech development, dental alignment, and facial appearance over time. The goal is to identify the safest, most effective surgical approach to guide cleft care for future families.

At a glance

Status

Completed

Enrolment target

450

Start

01 Sep 1997

Estimated completion

11 Nov 2006

Complete unilateral cleft lip and palate

What is this study about?

During early pregnancy, the different parts of a baby's face, lips, and roof of the mouth normally fuse together. Sometimes these parts do not join completely, leaving a gap known as a cleft. When a baby has a complete cleft on one side (unilateral cleft lip and palate), the opening extends through the upper lip, the upper gum, and both the hard and soft parts of the roof of the mouth.

Closing this gap requires surgery early in childhood. These first operations are vital because they set the foundation for how a child will look, speak, hear, and chew as they grow up. They can also influence whether a child will need further corrective operations during their school years or adolescence. However, cleft surgeons across the world have long debated the exact best age and sequence for closing the lip and palate.

The Scandcleft project was created to provide clear, reliable evidence to settle this debate. By comparing four carefully planned surgical timings across specialist cleft centres in the UK, Denmark, Finland, Norway, and Sweden, the project looks at how each technique affects long-term speech, jaw growth, and overall facial appearance. This helps doctors ensure that every child receives the best possible care from day one.

Key takeaways

Scandcleft compares four established surgical timelines for repairing one-sided cleft lip and palate in babies.
Operations take place in planned stages between 3 months and 3 years of age.
Researchers track long-term speech, dental development, jaw growth, and facial appearance into the late teens.
All operations are performed by expert surgeons at specialist regional cleft centres.
Participation is voluntary and does not affect your child's right to full NHS cleft care.

Who may be eligible?

This study was designed for newborn babies who have a complete cleft lip and palate affecting one side of the face only. The cleft must be 'non-syndromic', which means it is an isolated condition and not part of a broader genetic syndrome affecting other organs or general development. Babies who have a tiny bridge of skin across the cleft (called a Simonart's band) could take part, provided this tissue bridge was 5 millimetres or narrower.

Because a major part of the study involves tracking speech and language development over many years, the baby's family had to speak the primary language of their country (such as English in the UK) at home. This ensures that speech assessments can be fairly and accurately compared.

Babies were not able to take part if they had a cleft affecting both sides of the face, a wider tissue bridge across the cleft, an associated genetic syndrome, or if the main language spoken at home was different from the local language used for speech testing.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Baby was born with a complete cleft of the lip and palate on one side only.
The cleft is not part of a wider genetic syndrome or other major health condition.
Any skin bridge across the cleft is 5 millimetres or less in width.
The primary language of your country (such as English in the UK) is spoken at home.
Care is being received at one of the participating specialist cleft centres.

Answer every question to see your result.

What does participation involve?

If a child took part in the study, they were randomly placed into one of four surgical groups using a computer. Each group tested a different, safe surgical schedule: - Group 1: The lip and soft palate are repaired at 3 to 4 months of age, and the hard palate is repaired at 12 months. - Group 2: The lip and soft palate are repaired at 3 to 4 months, and the hard palate is repaired at 36 months (3 years). - Group 3: The lip is repaired at 3 to 4 months, and both the hard and soft palate are repaired at 12 months. - Group 4: The lip and hard palate are repaired at 3 to 4 months, and the soft palate is repaired at 12 months.

All operations are performed under general anaesthetic by experienced cleft surgeons in specialist hospitals. Following the operations, the child attends routine clinic visits to check healing and growth. Because children continue to develop until adulthood, researchers follow their progress over several years, collecting records on speech, hearing, jaw growth, dental health, and facial appearance until their late teens.

Potential risks and benefits

Every operation carries standard risks, including bleeding, wound infection, reactions to anaesthesia, and temporary difficulties with feeding while the mouth heals. However, all four surgical options in this trial are standard, well-tested methods performed by expert surgical teams. Taking part may not provide direct medical benefits beyond high-quality cleft care, but participants benefit from thorough, long-term monitoring that catches any speech or dental issues early. The study also helps future children by identifying the best surgical timings. Taking part is completely voluntary, and parents can withdraw their child from the study at any time without it affecting the child's ordinary NHS treatment.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Manchester Cleft Centre
City only
Manchester, England
Royal Belfast Hospital for Sick Children
Unverified
Belfast NO COUNTRY SPECIFIED, assuming England, England
Copenhagen/Aarhus Cleft and Craniofacial Centre
City only
Copenhagen, Denmark
Helsinki Cleft and Craniofacial Centre
City only
Helsinki, Finland
Gothenburg Cleft and Craniofacial Centre
City only
Gothenburg, Sweden
Linköping Cleft and Craniofacial Centre
City only
Linköping, Sweden
Stockholm Cleft and Craniofacial
Unverified
Stockholm, Sweden
Oslo Cleft and Craniofacial
Unverified
Oslo, Norway
Bergen Cleft and Craniofacial
Unverified
Bergen, Norway

Common questions

Why is cleft surgery often split into multiple operations?

Repairing the lip and palate in stages allows delicate facial tissues to heal properly and allows the mouth and jaw to grow naturally between procedures.

Can parents choose which surgical schedule their baby receives?

No. To keep the comparison scientifically fair and unbiased, a computer randomly assigns each baby to one of the four study groups.

Are all four surgical techniques safe?

Yes. All four approaches are established techniques used safely by specialist surgeons across the UK and internationally.

How long will my child be followed up in the study?

Because speech, teeth, and facial bones continue to grow throughout childhood, the study monitors children's progress right up into their late teenage years.

What happens if we want to leave the study?

You can leave the trial at any point without giving a reason. Your child will continue to receive the same dedicated cleft care from their NHS specialist team.

How to find out more

Gunvor Semb

gunvor.semb@manchester.ac.uk +44- (0)161-2756809 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.