Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.

Assiut University

Status: Not yet enrolling

Conditions: Cleft Lip, Unilateral

Treatments: Procedure: Millard and Tension Randal Technique

Study type: Observational

Funder types: Other

Identifiers

NCT06166238

Unilater cleft lip.

Details and patient eligibility

About

"the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of Operation Smile, a non- profit organization based in Virginia Beach, USA. Operation Smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. Under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.

Full description

One of the common congenital malformations in the head and neck is cleft lips. The prevalence of cleft lip is about 1:1000 of live birth; it also more common in boys and tends to present on the left side with a 6:3:1 ratio of left to right to bilateral. Many facial malformations, including cleft lip, are linked with environmental, maternal, and genetic factors, such as exposure to teratogen drugs, including isotretinoin, alcohol, or anticonvulsants. Similarly, some habits or diseases during pregnancy increase the risk of the cleft lip as smoking, pregestational and gestational diabetes, and specific nutritional deficiencies. The treatment begins soon after the child's birth and continues until adulthood. The purpose of cleft treatment is aesthetic and functional rehabilitation. Surgical repair is important for facial growth preservation, normal speech formation and development of proper dentition. The less number of interventions, the less the scaring results and hence, growth retardation Nowadays, the most commonly used techniques in managing unilateral cleft lip (UCL) are Millard's rotation advancement and Tennison Randall's triangular flap repairs. This study aimed to use anthropometric analysis by anthropometric measurements taken pre and post operation to evaluate the quantitative assessment of the modified Millard technique compared with the Tennison Randall technique in UCL repair.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients are generally fit
• Patients with unilateral with or without cleft palate
• Patients with compliance for follow up.

Exclusion criteria

• Syndromic cases.
• Patients are generally unfit.
• Secondary cleft lip.
• Age less than 3 months, more than 4 years
• Bilateral cleft lip.

Trial design

30 participants in 2 patient groups

Group I

Description:

Patients who will be subjected to Millard Technique

Treatment:

Procedure: Millard and Tension Randal Technique

Group II

Description:

patients who will be subjected to Tension Randal

Treatment:

Procedure: Millard and Tension Randal Technique