While the oral health-related quality of life (OHRQoL) is known to be reduced in patients with cleft lip and palate (CLP), its inter-dependency with the soft tissue characteristics of the CLP area remains unclear. This study aimed to evaluate the soft tissue characteristics in the treated cleft area in order to investigate whether gingival esthetics correlate with OHRQoL. Thirty-six patients with unilateral or bilateral CLP (46 cleft areas) were investigated after secondary/tertiary alveolar bone grafting and orthodontic/prosthetic implant treatment using an adapted score to rate gingival esthetics (clinical esthetic score, CES). The patient’s OHRQoL was determined using the German short version of the Oral Health Impact Profile questionnaire (OHIP-G14). The results showed a significantly better rating in patients with their own teeth in situ (12.05 ± 1.10) than in patients with implants (6.95 ± 4.78) or prosthetics (4.00 ± 3.58). The best OHRQoL values were achieved by patients with their own teeth integrated into the cleft area (1.32 ± 2.31), followed by patients with implants (2.33 ± 2.33) and prosthetics (3.75 ± 5.87). A significant ( P = 0.017) correlation was found between OHIP-G14 and CES scores, suggesting an increased OHRQoL in cases with higher oral esthetics in the cleft area. The therapeutic strategy contributes to both gingival esthetics and OHRQoL. The patient’s subjective perception of OHRQoL can be attributed to objective gingival esthetic ratings.
With an incidence of approximately one in every 500–1100 live births, the development of a cleft lip and/or palate (CLP) is one of the most common congenital malformations worldwide . The established surgical treatment for closure of the cleft alveolar ridge is the alveolar bone graft. With this treatment, cancellous bone from, for example, the iliac spine, mandible, or tibia is placed in the cleft region and covered with a mucoperiosteal flap .
Despite the complex therapy strategies, the surgical treatment of patients with CLP is a well-established procedure with reported success rates ranging from 73% to 93% based on the functional outcome and anatomical parameters .
Many different rating criteria, from skeletal growth of the midface to the nasolabial esthetic appearance, have been applied to assess the success of CLP treatment . However, objectively successful treatment does not necessarily equal satisfied patients: poor patient information, patient self-perception, and unrealistic treatment outcome expectations may produce a mismatch between professional expert ratings and individual patient ratings .
In this context, both objective and subjective parameters for successful treatment have been shown to influence the patient’s oral health-related quality of life (OHRQoL), which is defined as the subjective perception of how one’s well-being is affected by functional, psychological, and social factors related to oral health. This includes self-esteem, experiencing pain or discomfort, and the esthetic oral appearance .
The condition and shape of the gingiva is seen as a main criterion for the esthetic oral appearance. Surgical treatment may lead to soft tissue scarring and influence the overall gingival appearance, and periodontal diseases are known to manifest more frequently in patients with CLP. There is, however, no standardized scoring system to objectively rate the esthetic oral soft tissue appearance of patients with CLP .
In the present study, a scoring system was developed based on the seven variables included in the ‘pink esthetic score’ (PES) of Furhauser et al. . The German short version of the Oral Health Impact Profile questionnaire (OHIP-G14) was used to assess OHRQoL . The aim of the study was to investigate which dental and surgical treatment options are most likely to positively influence the oral esthetic appearance and to identify the impact of gingival esthetics on OHRQoL in this group of patients.
Materials and methods
Thirty-six patients (20 male, 16 female) with unilateral or bilateral CLP were examined ( Table 1 ). All patients had undergone secondary or tertiary alveolar bone grafting at least 6 months prior to the examination. To avoid any bias in the outcome of gingival esthetics, all surgical procedures were performed by the same surgical team. Patients under 12 and over 40 years of age were excluded from the study to prevent any bias resulting from gingival alterations . Those cases with incomplete eruption of the teeth in or around the treated cleft area were also excluded. No patient included in the study revealed any sign of a systemic disease that might have influenced the outcome of the OHIP-G14 or CES scores.
|Patients ( n )||26||10||36|
|Cleft sites||26||Left 10||Right 10||46|
Esthetic appearance of oral soft tissue
The gingival esthetic appearance was measured using seven variables derived from the ‘clinical esthetic score’ (CES), based on the PES ( Table 2 ). The data were collected by a senior oral and maxillofacial surgeon during regular clinical examinations in the outpatient clinic.
|1||Mesial papilla||Characteristics compared to reference tooth||Absent||Incomplete||Complete|
|2||Distal papilla||Characteristics compared to reference tooth||Absent||Incomplete||Complete|
|3||Level of soft tissue||Level compared to reference tooth||Difference > 2 mm||Difference 1–2 mm||Difference < 1 mm|
|4||Shape of soft tissue||Naturalness compared to reference tooth||Unnatural form||Rather natural form||Natural form|
|5||Alveolar crest||Deficit on alveolar crest||Distinct deficit||Small deficit||No deficit|
|6||Naturalness of soft tissue color||Color compared to reference tooth||Distinct difference||Moderate difference||No difference|
|7||Structure of soft tissue||Structure compared to reference tooth||Distinct difference||Moderate difference||No difference|
The investigated area was defined as the teeth, implants, or dental prostheses (including dental crowns and bridges) in the treated former cleft region, as well as the mesial and distal teeth adjacent to it (mesial tooth + former cleft + distal tooth). To allow for the assessment of unilateral as well as bilateral CLP cases in an unbiased manner, all cases were rated relative to the healthy standard dentition of a 20-year-old male. A score ranging from 0 (worst possible appearance relative to reference dentition) to 2 (best possible appearance relative to reference dentition) was assigned to each variable. Thus, a total value of between 0 (worst) and 14 (best) could be scored to represent the esthetic gingival appearance of each tooth, prosthesis/crown/bridge, or implant in the treated cleft region in relation to the healthy standard dentition. The mean ± standard deviation values for each region (tooth, implant, or prosthesis in the cleft, as well as the mesial and distal teeth/implants/prostheses/crowns/bridges adjacent to it) and the total value were calculated.
For the statistical analysis, every cleft area was defined as a single case, resulting in 46 rated sites for 36 patients (26 unilateral CLP, 10 bilateral CLP). These cases were then classified according to the type of dental treatment found in the cleft region: (1) patients with their own tooth in situ (‘tooth’ cohort); (2) patients with an implant in situ (‘implant’ cohort); (3) patients with dentures/crowns/bridges in situ (‘prosthetic’ cohort).
Oral health-related quality of life
Patients were asked to complete the OHIP-G14, derived from the 2002 version by John et al. . This German short version is based on the original questionnaire . The questionnaire comprises the seven domains ‘functional limitation’ (two questions), ‘handicap’ (one question), ‘physical disability’ (three questions), ‘physical pain’ (two questions), ‘psychological disability’ (one question), ‘psychological discomfort’ (three questions), and ‘social disability’ (two questions) ( Table 3 ).
|OHIP variables||Dental treatment|
|Own tooth||Implant||Prosthetic||Total ( n )|
|n = 22||n = 6||n = 8||n = 36|
|1. Trouble pronouncing words||0.09 ± 0.29||1.17 ± 1.60||0.63 ± 1.41||0.39 ± 0.99|
|2. Sense of taste worsened||0.14 ± 0.64||0 ± 0.00||0 ± 0.00||0.08 ± 0.50|
|3. Life less satisfying||0.05 ± 0.21||0 ± 0.00||0.38 ± 0.52||0.11 ± 0.32|
|4. Difficulty relaxing||0.14 ± 0.64||0 ± 0.00||0.63 ± 1.06||0.22 ± 0.72|
|5. Felt tense||0.09 ± 0.29||0.17 ± 0.41||0.63 ± 1.19||0.22 ± 0.64|
|6. Interrupted meals||0.05 ± 0.21||0 ± 0.00||0 ± 0.00||0.03 ± 0.17|
|7. Uncomfortable eating||0.05 ± 0.21||0.33 ± 0.82||0 ± 0.00||0.08 ± 0.37|
|8. Irritable with other people||0.09 ± 0.29||0 ± 0.00||0.50 ± 1.07||0.17 ± 0.56|
|9. Difficulty doing usual activities||0 ± 0.00||0 ± 0.00||0.25 ± 0.71||0.06 ± 0.33|
|10. Unable to function||0 ± 0.00||0 ± 0.00||0.13 ± 0.35||0.03 ± 0.17|
|11. Anxiety/depression||0.18 ± 0.50||0 ± 0.00||0.25 ± 0.46||0.17 ± 0.45|
|12. Diet unsatisfactory||0 ± 0.00||0 ± 0.00||0 ± 0.00||0 ± 0.00|
|13. Pain/discomfort||0.32 ± 0.57||0.33 ± 0.82||0.25 ± 0.71||0.31 ± 0.62|
|14. Insecurity||0.14 ± 0.47||0.33 ± 0.82||0.13 ± 0.35||0.17 ± 0.51|
|Total OHIP score||1.32 ± 2.32 a||2.33 ± 2.34 a||3.75 ± 5.87 a||2.03 ± 3.45|
A total of 14 items are rated on a five-point scale, with possible answers ranging from ‘very often’ to ‘never’; response values ranging from 4 to 0 are assigned to each answer. Each question is weighted the same; the maximum possible score is 56 points (worst possible result) and the lowest possible score is 0 points (best possible result). Higher scores thus indicate a lower OHRQoL experienced by the patients during the past month. The OHIP-G14 results were categorized into groups depending on the dental treatment, type of osteoplasty, age, and sex. The mean values were calculated for each topic of the questionnaire, as well as for the total scores. In accordance with prior works by Eitner et al. and Szentpetery et al., categories including responses of ‘fairly often’ and ‘very often’ were considered to be ‘frequently reported problems’ .
All data derived from the patient examinations and questionnaires were analyzed using IBM SPSS Statistics version 21.0 (IBM Corp., Armonk, NY, USA). The Levene test was used to test for the homogeneity of variance and the one-sample Kolmogorov–Smirnov test was used for the proof of normal distribution. If not indicated otherwise, these preconditions were given for all calculations.
To compare non-parametric data, the analysis was performed using the Kruskal–Wallis H -test for multiple samples (α = 0.05). Pairwise comparisons were conducted using the Mann–Whitney U -test (α = 0.05) and the Wilcoxon signed rank test for paired samples.
Spearman rank correlation analysis was used to test for correlation between the OHIP-G14 and CES scores, as well as between OHIP-G14 scores and the type of dental therapy (own tooth, implant, prosthetic).
In those cases with a bilateral CLP, only the site showing the worst esthetic appearance was examined for correlation to the OHIP-G14 score, as the side with the more compromised gingival appearance was assumed to have a greater influence on oral health-related self-perception.
A total of 36 patients with 46 cleft areas were examined in this study. A bilateral CLP was found in 10 patients and a unilateral CLP in 26 patients (16 left, 10 right). Twenty-five patients were treated with secondary alveolar bone grafting and 11 with tertiary alveolar bone grafting. The patients ranged in age from 12 to 37 years (mean 21.92 ± 5.30 years). The mean age of patients who underwent secondary bone grafting was 19.32 ± 2.57 years (range 12–24 years) and the mean age of the patients who underwent tertiary osteoplastic surgery was 27.82 ± 5.23 years (range 12–37 years). The dental status in the cleft region showed own teeth in situ for 26 patients (nine lateral incisors, 17 canine teeth), 13 dental prostheses (fixed and non-fixed prostheses/crowns/bridges), and seven implants ( Table 1 ).
Esthetic appearance of oral soft tissue
The CES values (mean and standard deviation) for each cohort (tooth, implant, prosthetic; primary or secondary bone grafting) are shown in Tables 4 and 5 .
|Dental treatment in cleft||Total|
|Number of sites||26||7||13||46|
|Mesial tooth||11.31 ± 2.07||7.14 ± 4.98||3.92 ± 5.13||8.59 ± 4.86|
|Cleft region||11.46 ± 1.67||5.00 ± 5.13||1.92 ± 2.87||7.78 ± 5.12|
|Distal tooth||13.38 ± 0.85||8.71 ± 5.79||6.15 ± 4.87||10.63 ± 4.68 b|
|Total cleft area||12.05 ± 1.10 b||6.95 ± 4.78||4.00 ± 3.58||9.00 ± 4.51|